Publications by authors named "Hany Abdel-Aleem"

32 Publications

Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth.

N Engl J Med 2018 Aug 27;379(8):743-752. Epub 2018 Jun 27.

From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); Statistika Consultoria, Campinas, Brazil (G.P., J.F.C.); the Department of Obstetrics and Gynecology, School of Medicine, University of Nairobi, Nairobi, Kenya (A.O., Z.Q.); the Department of Obstetrics and Gynecology, Mother and Child Hospital, Akure (O.O.O.), and the Department of Obstetrics and Gynecology, College of Medicine, University of Ibadan, Ibadan (B.F.) - both in Nigeria; Sriram Chandra Bhanja Medical College, Cuttack (S.M.), S. Nijalingappa Medical College and Hangal Shri Kumareshwar Hospital and Medical Research Center (A.A.M.), Karnatak Lingayat Education Academy of Higher Education and Research, Jawaharlal Nehru Medical College (S.S.G., Y.V.P.), and Shri B.M. Patil Medical College, Hospital and Research Center (S.S.S.), Karnataka, Lata Medical Research Foundation and Daga Women's Hospital, Maharashtra (A.B.P.), and the Department of Obstetrics and Gynecology, Institute of Medical Sciences, Banaras Hindu University, Varanasi (U.P.) - all in India; the Institute of Metabolism and Systems Research, University of Birmingham, Birmingham (A.C.), and the Department of Obstetrics and Gynaecology, University of Liverpool, Liverpool (J.N.) - both in the United Kingdom; the Department of Obstetrics and Gynecology, Women's Health Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt (H.A.-A.); the Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand (P.L.); Centro Rosarino de Estudios Perinatales, Rosario, Argentina (G.C., D.G.); the Effective Care Research Unit, Universities of Witwatersrand-Johannesburg, Fort Hare-Alice, and Walter Sisulu-Eastern Cape, and the Eastern Cape Department of Health, Eastern Cape - all in South Africa (G.J.H.); the Department of Obstetrics and Gynecology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore (L.L.S.); and the Department of Obstetrics and Gynecology, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda (K.M., J.B.).

Background: Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin.

Methods: We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 μg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively.

Results: A total of 29,645 women underwent randomization. The frequency of blood loss of at least 500 ml or the use of additional uterotonic agents was 14.5% in the carbetocin group and 14.4% in the oxytocin group (relative risk, 1.01; 95% confidence interval [CI], 0.95 to 1.06), a finding that was consistent with noninferiority. The frequency of blood loss of at least 1000 ml was 1.51% in the carbetocin group and 1.45% in the oxytocin group (relative risk, 1.04; 95% CI, 0.87 to 1.25), with the confidence interval crossing the margin of noninferiority. The use of additional uterotonic agents, interventions to stop bleeding, and adverse effects did not differ significantly between the two groups.

Conclusions: Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).
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http://dx.doi.org/10.1056/NEJMoa1805489DOI Listing
August 2018

The World Health Organization Fetal Growth Charts: A Multinational Longitudinal Study of Ultrasound Biometric Measurements and Estimated Fetal Weight.

PLoS Med 2017 01 24;14(1):e1002220. Epub 2017 Jan 24.

David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, United States of America.

Background: Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Against this background, WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use.

Methods And Findings: We conducted a multinational prospective observational longitudinal study of fetal growth in low-risk singleton pregnancies of women of high or middle socioeconomic status and without known environmental constraints on fetal growth. Centers in ten countries (Argentina, Brazil, Democratic Republic of the Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand) recruited participants who had reliable information on last menstrual period and gestational age confirmed by crown-rump length measured at 8-13 wk of gestation. Participants had anthropometric and nutritional assessments and seven scheduled ultrasound examinations during pregnancy. Fifty-two participants withdrew consent, and 1,387 participated in the study. At study entry, median maternal age was 28 y (interquartile range [IQR] 25-31), median height was 162 cm (IQR 157-168), median weight was 61 kg (IQR 55-68), 58% of the women were nulliparous, and median daily caloric intake was 1,840 cal (IQR 1,487-2,222). The median pregnancy duration was 39 wk (IQR 38-40) although there were significant differences between countries, the largest difference being 12 d (95% CI 8-16). The median birthweight was 3,300 g (IQR 2,980-3,615). There were differences in birthweight between countries, e.g., India had significantly smaller neonates than the other countries, even after adjusting for gestational age. Thirty-one women had a miscarriage, and three fetuses had intrauterine death. The 8,203 sets of ultrasound measurements were scrutinized for outliers and leverage points, and those measurements taken at 14 to 40 wk were selected for analysis. A total of 7,924 sets of ultrasound measurements were analyzed by quantile regression to establish longitudinal reference intervals for fetal head circumference, biparietal diameter, humerus length, abdominal circumference, femur length and its ratio with head circumference and with biparietal diameter, and EFW. There was asymmetric distribution of growth of EFW: a slightly wider distribution among the lower percentiles during early weeks shifted to a notably expanded distribution of the higher percentiles in late pregnancy. Male fetuses were larger than female fetuses as measured by EFW, but the disparity was smaller in the lower quantiles of the distribution (3.5%) and larger in the upper quantiles (4.5%). Maternal age and maternal height were associated with a positive effect on EFW, particularly in the lower tail of the distribution, of the order of 2% to 3% for each additional 10 y of age of the mother and 1% to 2% for each additional 10 cm of height. Maternal weight was associated with a small positive effect on EFW, especially in the higher tail of the distribution, of the order of 1.0% to 1.5% for each additional 10 kg of bodyweight of the mother. Parous women had heavier fetuses than nulliparous women, with the disparity being greater in the lower quantiles of the distribution, of the order of 1% to 1.5%, and diminishing in the upper quantiles. There were also significant differences in growth of EFW between countries. In spite of the multinational nature of the study, sample size is a limiting factor for generalization of the charts.

Conclusions: This study provides WHO fetal growth charts for EFW and common ultrasound biometric measurements, and shows variation between different parts of the world.
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http://dx.doi.org/10.1371/journal.pmed.1002220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5261648PMC
January 2017

Usefulness of the WHO C-Model to optimize the cesarean delivery rate in a tertiary hospital setting.

Int J Gynaecol Obstet 2017 Apr 31;137(1):40-44. Epub 2017 Jan 31.

Department of Obstetrics and Gynecology, Women's Health Hospital, Assiut, Egypt.

Objective: To assess use of the C-Model in a tertiary hospital setting in terms of its validity and utility for optimizing the cesarean delivery (CD) rate.

Methods: A prospective observational study included women admitted for delivery at a university teaching hospital in Assiut, Egypt, in 2015. The women were asked about the demographic and obstetric information needed to calculate the probability of CD using the WHO C-Model. A receiver operating characteristic (ROC) curve comparing the predicted and observed CD rates was constructed. In addition, the mean predicted CD rates were compared with the mean observed CD rates in the 10 groups of the Robson classification.

Results: In total, 1000 women were recruited; 38.6% had a previous CD and 13.5% had complications during the current pregnancy. The final mode of delivery was vaginal delivery in 38.7% and CD in 61.3%; the predicted CD rate for this cohort was 45.0%. The area under the ROC curve was 0.928 (95% confidence interval 0.912-0.945). Comparison of the predicted and observed CD rates in the 10 Robson groups showed an overuse of CD ranging from 2% to 50%.

Conclusion: The WHO C-Model is valid and can be used in hospital settings to optimize CD rates.
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http://dx.doi.org/10.1002/ijgo.12092DOI Listing
April 2017

Mobile clinics for women's and children's health.

Cochrane Database Syst Rev 2016 Aug 11(8):CD009677. Epub 2016 Aug 11.

Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University Hospital, Assiut, Assiut, Egypt, 71511.

Background: The accessibility of health services is an important factor that affects the health outcomes of populations. A mobile clinic provides a wide range of services but in most countries the main focus is on health services for women and children. It is anticipated that improvement of the accessibility of health services via mobile clinics will improve women's and children's health.

Objectives: To evaluate the impact of mobile clinic services on women's and children's health.

Search Methods: For related systematic reviews, we searched the Database of Abstracts of Reviews of Effectiveness (DARE), CRD; Health Technology Assessment Database (HTA), CRD; NHS Economic Evaluation Database (NHS EED), CRD (searched 20 February 2014).For primary studies, we searched ISI Web of Science, for studies that have cited the included studies in this review (searched 18 January 2016); WHO ICTRP, and ClinicalTrials.gov (searched 23 May 2016); Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library. www.cochranelibrary.com (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register) (searched 7 April 2015); MEDLINE, OvidSP (searched 7 April 2015); Embase, OvidSP (searched 7 April 2015); CINAHL, EbscoHost (searched 7 April 2015); Global Health, OvidSP (searched 8 April 2015); POPLINE, K4Health (searched 8 April 2015); Science Citation Index and Social Sciences Citation Index, ISI Web of Science (searched 8 April 2015); Global Health Library, WHO (searched 8 April 2015); PAHO, VHL (searched 8 April 2015); WHOLIS, WHO (searched 8 April 2015); LILACS, VHL (searched 9 April 2015).

Selection Criteria: We included individual- and cluster-randomised controlled trials (RCTs) and non-RCTs. We included controlled before-and-after (CBA) studies provided they had at least two intervention sites and two control sites. Also, we included interrupted time series (ITS) studies if there was a clearly defined point in time when the intervention occurred and at least three data points before and three after the intervention. We defined the intervention of a mobile clinic as a clinic vehicle with a healthcare provider (with or without a nurse) and a driver that visited areas on a regular basis. The participants were women (18 years or older) and children (under the age of 18 years) in low-, middle-, and high-income countries.

Data Collection And Analysis: Two review authors independently screened the titles and abstracts of studies identified by the search strategy, extracted data from the included studies using a specially-designed data extraction form based on the Cochrane EPOC Group data collection checklist, and assessed full-text articles for eligibility. All authors performed analyses, 'Risk of bias' assessments, and assessed the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Main Results: Two cluster-RCTs met the inclusion criteria of this review. Both studies were conducted in the USA.One study tested whether offering onsite mobile mammography combined with health education was more effective at increasing breast cancer screening rates than offering health education only, including reminders to attend a static clinic for mammography. Women in the group offered mobile mammography and health education may be more likely to undergo mammography within three months of the intervention than those in the comparison group (55% versus 40%; odds ratio (OR) 1.83, 95% CI 1.22 to 2.74; low certainty evidence).A cost-effectiveness analysis of mammography at mobile versus static units found that the total cost per patient screened may be higher for mobile units than for static units. The incremental costs per patient screened for a mobile over a stationary unit were USD 61 and USD 45 for a mobile full digital unit and a mobile film unit respectively.The second study compared asthma outcomes for children aged two to six years who received asthma care from a mobile asthma clinic and children who received standard asthma care from the usual (static) primary provider. Children who receive asthma care from a mobile asthma clinic may experience little or no difference in symptom-free days, urgent care use and caregiver-reported medication use compared to children who receive care from their usual primary care provider. All of the evidence was of low certainty.

Authors' Conclusions: The paucity of evidence and the restricted range of contexts from which evidence is available make it difficult to draw conclusions on the impacts of mobile clinics on women's and children's health compared to static clinics. Further rigorous studies are needed in low-, middle-, and high-income countries to evaluate the impacts of mobile clinics on women's and children's health.
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http://dx.doi.org/10.1002/14651858.CD009677.pub2DOI Listing
August 2016

Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial.

Trials 2016 Mar 17;17(1):143. Epub 2016 Mar 17.

Department of Reproductive Health and Research, World Health Organization, UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Avenue Appia 20, Geneva, 1201, Switzerland.

Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth.

Methods/design: Approximately 30,000 women delivering vaginally will be recruited across 22 centres in 10 countries. The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intramuscular) in the prevention of PPH and severe PPH after vaginal birth. The primary endpoints are blood loss ≥500 mL or the use of additional uterotonics (composite endpoint required by drug regulatory authorities) and blood loss ≥1,000 mL (WHO requirement). Non-inferiority will be assessed using a two-sided 95 % confidence interval for the relative risk of the above endpoints for room temperature stable carbetocin versus oxytocin. The upper limit of the two-sided 95 % confidence interval for the relative risk for the composite endpoint of blood loss ≥500 mL or the use of additional uterotonics, and for the endpoint of blood loss ≥1,000 mL, will be compared to a non-inferiority margin of 1.16 and 1.23, respectively. If the upper limit is below the corresponding margin, non-inferiority will have been demonstrated. The safety analysis will include all women receiving treatment. Safety and tolerability will be assessed by a review of adverse events, by conducting inferential testing with significance levels for between-group comparisons.

Discussion: If the results of the study show that room temperature stable carbetocin is a safe and effective alternative to oxytocin, this could have a substantial impact on the prevention of postpartum haemorrhage and maternal survival worldwide.

Trial Registration: ACTRN12614000870651 (14 August 2014).
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http://dx.doi.org/10.1186/s13063-016-1271-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4794812PMC
March 2016

Nitroglycerin for management of retained placenta.

Cochrane Database Syst Rev 2015 Nov 12(11):CD007708. Epub 2015 Nov 12.

Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University Hospital, Assiut, Assiut, Egypt, 71511.

Background: Retained placenta affects 0.5% to 3% of women following delivery, with considerable morbidity if left untreated. Use of nitroglycerin (NTG), either alone or in combination with uterotonics, may be of value to minimise the need for manual removal of the placenta in theatre under anaesthesia.

Objectives: To evaluate the benefits and harms of NTG as a tocolytic, either alone or in addition to uterotonics, in the management of retained placenta.

Search Methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (14 January 2015), reference lists of retrieved studies and contacted experts in the field.

Selection Criteria: Any adequately randomised controlled trial (RCT) comparing the use of NTG, either alone or in combination with uterotonics, with no intervention or with other interventions in the management of retained placenta. All women having a vaginal delivery with a retained placenta, regardless of the management of the third stage of labour (expectant or active). We included all trials with haemodynamically stable women in whom the placenta was not delivered at least within 15 minutes after delivery of the baby.

Data Collection And Analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.

Main Results: We included three randomised controlled trials (RCTs) with 175 women. The three published RCTs compared NTG alone versus placebo. The detachment status of retained placenta was unknown in all three RCTs. Collectively, among the three included trials, two were judged to be at low risk of bias and the third trial was judged to be at high risk of bias for two domains: incomplete outcome data and selective reporting. The three trials reported seven out of 23 of the review's pre-specified outcomes.The primary outcome "manual removal of the placenta" was reported in all three studies. No differences were seen between NTG and placebo for manual removal of the placenta (average risk ratio (RR) 0.83, 95% confidence interval (CI) 0.47 to 1.46; women = 175; I² = 81%). A random-effects model was used because of evidence of substantial heterogeneity in the analysis. There were also no differences between groups for risk of severe postpartum haemorrhage (RR 0.93, 95% CI 0.62 to 1.39; women = 150; studies = two; I² = 0%). Blood transfusion was only reported in one study (40 women) and again there was no difference between groups (RR 1.00, 95% CI 0.07 to 14.90; women = 40; I² = 0%). Mean blood loss (mL) was reported in the three studies and no differences were observed (mean difference (MD) -115.31, 95% CI -306.25 to 75.63; women = 169; I² = 83%). Nitroglycerin administration was not associated with an increase in headaches (RR 1.09, 95% CI 0.80 to 1.47; women = 174; studies = three; I² = 0%). However, nitroglycerin administration was associated with a significant, though mild, decrease in systolic and diastolic blood pressure and a significant increase in pulse rate (MD -3.75, 95% CI -7.47 to -0.03) for systolic blood pressure, and (MD 6.00, 95% CI 3.07 to 8.93) for pulse rate (beats per minute) respectively (reported by only one study including 24 participants). Maternal mortality and addition of therapeutic uterotonics were not reported in any study.

Authors' Conclusions: In cases of retained placenta, currently available data showed that the use of NTG alone did not reduce the need for manual removal of placenta. This intervention did not increase the incidence of severe postpartum haemorrhage nor the need for blood transfusion. Haemodynamically, NTG had a significant though mild effect on both pulse rate and blood pressure.
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http://dx.doi.org/10.1002/14651858.CD007708.pub3DOI Listing
November 2015

WHO multicentre study for the development of growth standards from fetal life to childhood: the fetal component.

BMC Pregnancy Childbirth 2014 May 2;14:157. Epub 2014 May 2.

UNDP/UNFPA/UNICEF/WHO/WORLD BANK Special Programme of Research, Development and Research Training in Human Reproduction; Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Background: In 2006 WHO presented the infant and child growth charts suggested for universal application. However, major determinants for perinatal outcomes and postnatal growth are laid down during antenatal development. Accordingly, monitoring fetal growth in utero by ultrasonography is important both for clinical and scientific reasons. The currently used fetal growth references are derived mainly from North American and European population and may be inappropriate for international use, given possible variances in the growth rates of fetuses from different ethnic population groups. WHO has, therefore, made it a high priority to establish charts of optimal fetal growth that can be recommended worldwide.

Methods: This is a multi-national study for the development of fetal growth standards for international application by assessing fetal growth in populations of different ethnic and geographic backgrounds. The study will select pregnant women of high-middle socioeconomic status with no obvious environmental constraints on growth (adequate nutritional status, non-smoking), and normal pregnancy history with no complications likely to affect fetal growth. The study will be conducted in centres from ten developing and industrialized countries: Argentina, Brazil, Democratic Republic of Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand. At each centre, 140 pregnant women will be recruited between 8 + 0 and 12 + 6 weeks of gestation. Subsequently, visits for fetal biometry will be scheduled at 14, 18, 24, 28, 32, 36, and 40 weeks (+/- 1 week) to be performed by trained ultrasonographers.The main outcome of the proposed study will be the development of fetal growth standards (either global or population specific) for international applications.

Discussion: The data from this study will be incorporated into obstetric practice and national health policies at country level in coordination with the activities presently conducted by WHO to implement the use of the Child Growth Standards.
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http://dx.doi.org/10.1186/1471-2393-14-157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4014086PMC
May 2014

Indwelling bladder catheterisation as part of intraoperative and postoperative care for caesarean section.

Cochrane Database Syst Rev 2014 Apr 11(4):CD010322. Epub 2014 Apr 11.

Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University Hospital, Assiut, Assiut, Egypt, 71511.

Background: Caesarean section (CS) is the most common obstetric surgical procedure, with more than one-third of pregnant women having lower-segment CS. Bladder evacuation is carried out as a preoperative procedure prior to CS. Emerging evidence suggests that omitting the use of urinary catheters during and after CS could reduce the associated increased risk of urinary tract infections (UTIs), catheter-associated pain/discomfort to the woman, and could lead to earlier ambulation and a shorter stay in hospital.

Objectives: To assess the effectiveness and safety of indwelling bladder catheterisation for intraoperative and postoperative care in women undergoing CS.

Search Methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 December 2013) and reference lists of retrieved studies.

Selection Criteria: Randomised controlled trials (RCTs) comparing indwelling bladder catheter versus no catheter or bladder drainage in women undergoing CS (planned or emergency), regardless of the type of anaesthesia used. Quasi-randomised trials, cluster-randomised trials were not eligible for inclusion. Studies presented as abstracts were eligible for inclusion providing there was sufficient information to assess the study design and outcomes.

Data Collection And Analysis: Two review authors independently assessed studies for eligibility and trial quality, and extracted data. Data were checked for accuracy.

Main Results: The search retrieved 16 studies (from 17 reports). Ten studies were excluded and one study is awaiting assessment. We included five studies involving 1065 women (1090 recruited). The five included studies were at moderate risk of bias.Data relating to one of our primary outcomes (UTI) was reported in four studies but did not meet our definition of UTI (as prespecified in our protocol). The included studies did not report on our other primary outcome - intraoperative bladder injury (this outcome was not prespecified in our protocol). Two secondary outcomes were not reported in the included studies: need for postoperative analgesia and women's satisfaction. The included studies did provide limited data relating to this review's secondary outcomes. Indwelling bladder catheter versus no catheter - three studies (840 women) Indwelling bladder catheterisation was associated with a reduced incidence of bladder distension (non-prespecified outcome) at the end of the operation (risk ratio (RR) 0.02, 95% confidence interval (CI) 0.00 to 0.35; one study, 420 women) and fewer cases of retention of urine (RR 0.06, 95% CI 0.01 to 0.47; two studies, 420 women) or need for catheterisation (RR 0.03, 95% CI 0.01 to 0.16; three studies 840 participants). In contrast, indwelling bladder catheterisation was associated with a longer time to first voiding (mean difference (MD) 16.81 hours, 95% CI 16.32 to 17.30; one study, 420 women) and more pain or discomfort due to catheterisation (and/or at first voiding) (average RR 10.47, 95% CI 4.71 to 23.25, two studies, 420 women) although high levels of heterogeneity were observed. Similarly, compared to women in the 'no catheter' group, indwelling bladder catheterisation was associated with a longer time to ambulation (MD 4.34 hours, 95% CI 1.37 to 7.31, three studies, 840 women) and a longer stay in hospital (MD 0.62 days, 95% CI 0.15 to 1.10, three studies, 840 women). However, high levels of heterogeneity were observed for these two outcomes and the results should be interpreted with caution.There was no difference in postpartum haemorrhage (PPH) due to uterine atony. There was also no difference in the incidence of UTI (as defined by trialists) between the indwelling bladder catheterisation and no catheterisation groups (two studies, 570 women). However, high levels of heterogeneity were observed for this non-prespecified outcome and results should be considered in this context. Indwelling bladder catheter versus bladder drainage - two studies (225 women)Two studies (225 women) compared the use of an indwelling bladder catheter versus bladder drainage. There was no difference between groups in terms of retention of urine following CS, length of hospital stay or the non-prespecified outcome of UTI (as defined by the trialist).There is some evidence (from one small study involving 50 women), that the need for catheterisation was reduced in the group of women with an indwelling bladder catheter (RR 0.04, 95% CI 0.00 to 0.70) compared to women in the bladder drainage group. Evidence from another small study (involving 175 women) suggests that women who had an indwelling bladder catheter had a longer time to ambulation (MD 0.90, 95% CI 0.25 to 1.55) compared to women who received bladder drainage.

Authors' Conclusions: This review includes limited evidence from five RCTs of moderate quality. The review's primary outcomes (bladder injury during operation and UTI), were either not reported or reported in a way not suitable for our analysis. The evidence in this review is based on some secondary outcomes, with heterogeneity present in some of the analyses. There is insufficient evidence to assess the routine use of indwelling bladder catheters in women undergoing CS. There is a need for more rigorous RCTs, with adequate sample sizes, standardised criteria for the diagnosis of UTI and other common outcomes.
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http://dx.doi.org/10.1002/14651858.CD010322.pub2DOI Listing
April 2014

Treatment of vaginal bleeding irregularities induced by progestin only contraceptives.

Cochrane Database Syst Rev 2013 Oct 21(10):CD003449. Epub 2013 Oct 21.

Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University Hospital, Assiut, Assiut, Egypt, 71511.

Background: Despite their high effectiveness, progestin-only contraceptives are considered less than ideal by the many women who experience irregular vaginal bleeding when using them. Current treatments to control these bleeding problems are not sufficiently effective.

Objectives: We evaluated preventive and therapeutic approaches to normalise bleeding irregularities associated with the use of progestin-only contraceptives.

Search Methods: Literature was identified through database searches, reference lists, organisations and individuals, covering the period until May-June 2012.

Selection Criteria: Trials with random or systematic allocation, testing interventions for the prevention or treatment of bleeding irregularities associated with the use of progestin-only contraceptives were eligible.

Data Collection And Analysis: Results are expressed as relative risks (RR) with 95% confidence interval (CI) for categorical data and as weighted mean difference (WMD) with 95% CI for continuous data. When we encountered heterogeneity (visual or statistical) we used the random-effects model (quantitative) or did not produce a summary estimate (qualitative).

Main Results: Thirty-three randomised controlled trials enrolling 3677 participants were included. Two thirds of the trials were determined to reflect low to moderate risk of bias.Estrogen treatments reduced the number of days of an ongoing bleeding episode in DMPA and Norplant users. However, treatment frequently led to more discontinuation due to gastrointestinal upset.Combinations of oral ethinyl estradiol and levonorgestrel improved bleeding patterns in Norplant users, but method discontinuation rates were unchanged. One trial reported successful use of combined oral contraceptives in treating amenorrhea among DMPA users.Norplant users, but not Implanon users, administered the anti-progestin mifepristone reported fewer days of bleeding during treatment than those given placebo. Mifepristone used monthly by new Norplant acceptors reduced bleeding, when compared to placebo.A variety of NSAIDS have been evaluated for their ability to treat abnormal bleeding, with mixed results.Norplant users receiving SERM (tamoxifen) had less unacceptable bleeding after treatment and were more likely to continue using Norplant than those receiving placebo.Tranexamic acid, mifepristone combined with an estrogen and doxycycline were more effective than placebo in terminating an episode of bleeding in women using progestin-only contraceptives, according to three small studies.

Authors' Conclusions: Some women may benefit from the interventions described, particularly with cessation of current bleeding. Several regimens offer promise in regulating bleeding, but findings need to be reproduced in larger trials. The results of this review do not support routine clinical use of any of the regimens included in the trials, particularly for long-term effect.
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http://dx.doi.org/10.1002/14651858.CD003449.pub5DOI Listing
October 2013

Analysis of cesarean delivery at Assiut University Hospital using the Ten Group Classification System.

Int J Gynaecol Obstet 2013 Nov 31;123(2):119-23. Epub 2013 Jul 31.

Department of Obstetrics and Gynecology, Women's Health Hospital, Assiut, Egypt. Electronic address:

Objective: To evaluate the feasibility of using the Robson Ten Group Classification System (TGCS) for cesarean delivery (CD) indications at institutional level.

Methods: Prospective clinical audits of women delivering by CD at Women's Health Hospital, Assiut, Egypt, were conducted in 2008 and 2011. The CD rates overall and in each Robson group were calculated, as was the contribution of each group to the overall CD rate. In addition, the CD indications in each group were analyzed.

Results: The CD rate was 32% (443/1357) in 2008 and 38% (626/1628) in 2011. The most common CD indication at both time intervals was a previous CD. Multiparas without uterine scar, a single cephalic term pregnancy, and spontaneous labor (Robson Group 3) comprised the largest group of women undergoing CD, followed by nulliparas with a single cephalic term pregnancy and spontaneous labor (Group 1), and multiparas with a scarred uterus and a single cephalic term pregnancy (Group 5). Group 5 was the largest contributor (30%) to the overall CD rate, followed by Groups 1 and 4 (10% each).

Conclusion: The TGCS can be applied at institutional level. It helps in planning strategies for specific subgroups of women to reduce CD rates and improve outcomes.
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November 2013

Treatment of vaginal bleeding irregularities induced by progestin only contraceptives.

Cochrane Database Syst Rev 2013 Jul 2(7):CD003449. Epub 2013 Jul 2.

Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University Hospital, Assiut, Egypt.

Background: Despite their high effectiveness, progestin-only contraceptives are considered less than ideal by the many women who experience irregular vaginal bleeding when using them. Current treatments to control these bleeding problems are not sufficiently effective.

Objectives: We evaluated preventive and therapeutic approaches to normalise bleeding irregularities associated with the use of progestin-only contraceptives.

Search Methods: Literature was identified through database searches, reference lists, organisations and individuals, covering the period until May-June 2012.

Selection Criteria: Trials with random or systematic allocation, testing interventions for the prevention or treatment of bleeding irregularities associated with the use of progestin-only contraceptives were eligible.

Data Collection And Analysis: Results are expressed as relative risks (RR) with 95% confidence interval (CI) for categorical data and as weighted mean difference (WMD) with 95% CI for continuous data. When we encountered heterogeneity (visual or statistical) we used the random-effects model (quantitative) or did not produce a summary estimate (qualitative).

Main Results: Thirty-three randomised controlled trials enrolling 3677 participants were included. Two thirds of the trials were determined to reflect low to moderate risk of bias.Estrogen treatments reduced the number of days of an ongoing bleeding episode in DMPA and Norplant users. However, treatment frequently led to more discontinuation due to gastrointestinal upset.Combinations of oral ethinyl estradiol and levonorgestrel improved bleeding patterns in Norplant users, but method discontinuation rates were unchanged. One trial reported successful use of combined oral contraceptives in treating amenorrhea among DMPA users.Norplant users, but not Implanon users, administered the anti-progestin mifepristone reported fewer days of bleeding during treatment than those given placebo. Mifepristone used monthly by new Norplant acceptors reduced bleeding, when compared to placebo.A variety of NSAIDS have been evaluated for their ability to treat abnormal bleeding, with mixed results.Norplant users receiving SERM (tamoxifen) had less unacceptable bleeding after treatment and were more likely to continue using Norplant than those receiving placebo.Tranexamic acid, mifepristone combined with an estrogen and doxycycline were more effective than placebo in terminating an episode of bleeding in women using progestin-only contraceptives, according to three small studies.

Authors' Conclusions: Some women may benefit from the interventions described, particularly with cessation of current bleeding. Several regimens offer promise in regulating bleeding, but findings need to be reproduced in larger trials. The results of this review do not support routine clinical use of any of the regimens included in the trials, particularly for long-term effect.
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July 2013

Uterine massage for preventing postpartum haemorrhage.

Cochrane Database Syst Rev 2013 Jul 1(7):CD006431. Epub 2013 Jul 1.

Department of Obstetrics and Gynaecology, East London Hospital Complex,University of the Witwatersrand, University of Fort Hare, Eastern Cape Department of Health, East London, South Africa.

Background: Postpartum haemorrhage (PPH) (bleeding from the genital tract after childbirth) is a major cause of maternal mortality and disability, particularly in under-resourced areas. In these settings, uterotonics are often not accessible. There is a need for simple, inexpensive techniques which can be applied in low-resourced settings to prevent and treat PPH. Uterine massage is recommended as part of the routine active management of the third stage of labour. However, it is not known whether it is effective. If shown to be effective, uterine massage would represent a simple intervention with the potential to have a major effect on PPH and maternal mortality in under-resourced settings.

Objectives: To determine the effectiveness of uterine massage after birth and before or after delivery of the placenta, or both, to reduce postpartum blood loss and associated morbidity and mortality.

Search Methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013).

Selection Criteria: All published, unpublished and ongoing randomised controlled trials comparing uterine massage alone or in addition to uterotonics before or after delivery of the placenta, or both, with non-massage.

Data Collection And Analysis: Two researchers independently considered trials for eligibility, assessed risk of bias and extracted the data using the agreed form. Data were checked for accuracy. The effect of uterine massage commenced before or after placental delivery were first assessed separately, and then the combined for an overall result.

Main Results: This review included two randomised controlled trials. The first trial included 200 women who were randomised to receive uterine massage or no massage following delivery of the placenta, after active management of the third stage of labour including use of oxytocin. The numbers of women with blood loss more than 500 mL was small, with no statistically significant difference (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.16 to 1.67). There were no cases of retained placenta in either group. The mean blood loss was significantly less in the uterine massage group at 30 minutes (mean difference (MD) -41.60 mL, 95% CI -75.16 to -8.04) and 60 minutes after trial entry (MD -77.40 mL, 95% CI -118.71 to -36.09). The need for additional uterotonics was significantly reduced in the uterine massage group (RR 0.20, 95% CI 0.08 to 0.50).For use of uterine massage before and after delivery of the placenta, one trial recruited 1964 women in Egypt and South Africa. Women were assigned to receive oxytocin, uterine massage or both after delivery of the baby but before delivery of the placenta. There was no added benefit for uterine massage plus oxytocin over oxytocin alone as regards blood loss greater than or equal to 500 mL (average RR 1.56, 95% CI 0.44, 5.49; random-effects) or need for additional use of uterotonics (RR 1.02, 95% CI 0.56 to 1.85).The two trials were combined to examine the effect of uterine massage commenced either before or after delivery of the placenta. There was substantial heterogeneity with respect to the blood loss 500 mL or more after trial entry. The average effect using a random-effects model found no statistically significant differences between groups (average RR 1.14, 95% CI 0.39 to 3.32; random-effects).

Authors' Conclusions: The results of this review are inconclusive, and should not be interpreted as a reason to change current practice. Due to the limitations of the included trials, more trials with sufficient numbers of women are needed in order to estimate the effects of sustained uterine massage. All the women compared in this review received oxytocin as part of the active management of labour. Recent research suggests that once an oxytocic has been given, there is limited scope for further reduction in postpartum blood loss. Trials of uterine massage in settings where uterotonics are not available, and which measure women's experience of the procedure, are needed.
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July 2013

Cervical pessary for preventing preterm birth.

Cochrane Database Syst Rev 2013 May 31(5):CD007873. Epub 2013 May 31.

Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University Hospital, Assiut, Egypt.

Background: Preterm birth is a major health problem and contributes to more than 50% of the overall perinatal mortality. Preterm birth has multiple risk factors including cervical incompetence and multiple pregnancy. Different management strategies have been tried to prevent preterm birth, including cervical cerclage. Cervical cerclage is an invasive technique that needs anaesthesia and may be associated with complications. Moreover, there is still controversy regarding the efficacy and the group of patients that could benefit from this operation. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.

Objectives: To evaluate the efficacy of cervical pessary for the prevention of preterm birth in women with risk factors for cervical incompetence.

Search Methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 September 2012), Current Controlled Trials and the Australian New Zealand Clinical Trials Registry (1 September 2012).

Selection Criteria: We selected all published and unpublished randomised clinical trials comparing the use of cervical pessary with cervical cerclage or expectant management for prevention of preterm birth. We did not include quasi-randomised trials. Cluster-randomised or cross-over trials were not eligible for inclusion.

Data Collection And Analysis: Two review authors independently assessed trials for inclusion.

Main Results: The review included one randomised controlled trial. The study included 385 pregnant women with a short cervix of 25 mm or less who were between 18 to 22 weeks of pregnancy. The use of cervical pessary (192 women) was associated with a statistically significantly decrease in the incidence of spontaneous preterm birth less than 37 weeks' gestation compared with expectant management (22% versus 59 %; respectively, risk ratio (RR) 0.36, 95% confidence interval (CI) 0.27 to 0.49). Spontaneous preterm birth before 34 weeks was statistically significantly reduced in the pessary group (6% and 27% respectively, RR 0.24; 95% CI 0.13 to 0.43). Mean gestational age at delivery was 37.7 + 2 weeks in the pessary group and 34.9 + 4 weeks in the expectant group. Women in the pessary group used less tocolytics (RR 0.63; 95% CI 0.50 to 0.81) and corticosteroids (RR 0.66; 95% CI 0.54 to 0.81) than the expectant group. Vaginal discharge was more common in the pessary group (RR 2.18; 95% CI 1.87 to 2.54). Among the pessary group, 27 women needed pessary repositioning without removal and there was one case of pessary removal. Ninety-five per cent of women in the pessary group would recommend this intervention to other people. Neonatal paediatric care admission was reduced in the pessary group in comparison to the expectant group (RR 0.17; 95% CI 0.07 to 0.42).

Authors' Conclusions: The review included only one well-designed randomised clinical trial that showed beneficial effect of cervical pessary in reducing preterm birth in women with a short cervix. There is a need for more trials in different settings (developed and developing countries), and with different risk factors including multiple pregnancy.
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http://dx.doi.org/10.1002/14651858.CD007873.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6491132PMC
May 2013

Active management of the third stage of labour with and without controlled cord traction: a randomised, controlled, non-inferiority trial.

Lancet 2012 May 6;379(9827):1721-7. Epub 2012 Mar 6.

UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland.

Background: Active management of the third stage of labour reduces the risk of post-partum haemorrhage. We aimed to assess whether controlled cord traction can be omitted from active management of this stage without increasing the risk of severe haemorrhage.

Methods: We did a multicentre, non-inferiority, randomised controlled trial in 16 hospitals and two primary health-care centres in Argentina, Egypt, India, Kenya, the Philippines, South Africa, Thailand, and Uganda. Women expecting to deliver singleton babies vaginally (ie, not planned caesarean section) were randomly assigned (in a 1:1 ratio) with a centrally generated allocation sequence, stratified by country, to placental delivery with gravity and maternal effort (simplified package) or controlled cord traction applied immediately after uterine contraction and cord clamping (full package). After randomisation, allocation could not be concealed from investigators, participants, or assessors. Oxytocin 10 IU was administered immediately after birth with cord clamping after 1-3 min. Uterine massage was done after placental delivery according to local policy. The primary (non-inferiority) outcome was blood loss of 1000 mL or more (severe haemorrhage). The non-inferiority margin for the risk ratio was 1·3. Analysis was by modified intention-to-treat, excluding women who had emergency caesarean sections. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN 12608000434392.

Findings: Between June 1, 2009, and Oct 30, 2010, 12,227 women were randomly assigned to the simplified package group and 12,163 to the full package group. After exclusion of women who had emergency caesarean sections, 11,861 were in the simplified package group and 11,820 were in the full package group. The primary outcome of blood loss of 1000 mL or more had a risk ratio of 1·09 (95% CI 0·91-1·31) and the upper 95% CI limit crossed the pre-stated non-inferiority margin. One case of uterine inversion occurred in the full package group. Other adverse events were haemorrhage-related.

Interpretation: Although the hypothesis of non-inferiority was not met, omission of controlled cord traction has very little effect on the risk of severe haemorrhage. Scaling up of haemorrhage prevention programmes for non-hospital settings can safely focus on use of oxytocin.

Funding: United States Agency for International Development and UN Development Programme/UN Population Fund/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research.
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May 2012

Doxycycline in the treatment of bleeding with DMPA: a double-blinded randomized controlled trial.

Contraception 2012 Sep 9;86(3):224-30. Epub 2012 Feb 9.

Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Egypt.

Background: Increased matrix metalloproteinase (MMP) activity in the endometrium is a predisposing factor for bleeding with depot medroxy progesterone acetate (DMPA) injectable contraception. Doxycycline (DOX) has been proven in vitro to inhibit MMP-mediated degradation of stromal matrix. The current study examined the effect of DOX compared to placebo in treating a current bleeding episode during DMPA use.

Study Design: A double-blinded randomized controlled trial was conducted in Assiut, Egypt. DMPA users with current bleeding episode were counseled to participate. Women who agreed to participate were randomly assigned to receive 100 mg DOX twice daily for 5 days (34 patients) or an identical placebo (34 patients). All participants were asked to report bleeding and spotting days in a menstrual diary. All participants were followed for 3 months after treatment. This trial was registered (NCT01254799).

Results: The relative risk to stop a bleeding episode within 10 days of starting treatment was 0.88 (confidence interval 0.64-1.21) in the treatment group compared to the control. DOX treatment caused no significant difference compared to placebo in the number of bleeding and/or spotting days in the 3 months following the treatment.

Conclusion: Doxycycline as MMP inhibitor is not effective in stopping a current attack of bleeding with DMPA. It also does not improve the bleeding characteristics of women for the subsequent 3 months following the treatment.
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September 2012

Tocolysis for management of retained placenta.

Cochrane Database Syst Rev 2011 Jan 19(1):CD007708. Epub 2011 Jan 19.

Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University Hospital, Assiut, Egypt, 71511.

Background: Retained placenta affects 0.5% to 3% of women following delivery, with considerable morbidity if left untreated. Use of tocolytics, either alone or in combination with uterotonics, may be of value to minimise the need for manual removal of the placenta in theatre under anaesthesia.

Objectives: Evaluate the benefits and harms of tocolytics alone or in addition to uterotonics in the management of retained placenta in order to reduce the need for manual removal of placenta.

Search Strategy: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2010) and contacted experts in the field.

Selection Criteria: Any adequately randomised controlled trial (RCT) comparing the use of tocolytics, either alone or in combination with uterotonics, with no intervention or with other interventions in the management of retained placenta. All women having a vaginal delivery with a retained placenta, regardless of the management of the third stage of labour (expectant or active). We included all trials with haemodynamically stable women in whom the placenta was not delivered at least within 15 minutes after delivery of the baby.

Data Collection And Analysis: Two review authors independently assessed trial quality and extracted data. Consultation of the third author was done if needed.

Main Results: We included one RCT (involving 24 women). It compared the use of nitroglycerin tablets versus placebo after the treatment with oxytocin failed. There was a statistically significant reduction in the need for manual removal of placenta (risk ratio (RR) 0.04, 95% confidence interval (CI) 0.00 to 0.66). There was also a statistically significant reduction in mean blood loss during the third stage of labour (mean difference (MD) -262.50 ml, 95% CI -364.95 to -160.05). Sublingual nitroglycerin caused some haemodynamic changes as it lowers the systolic blood pressure and diastolic blood pressure by a means of 6 and 5 mmHg respectively. Pulse rate increased by a mean of two beats per minute.

Authors' Conclusions: Sublingual nitroglycerin, given when oxytocin fails, seems to reduce both the need for manual removal of placenta and blood loss during the third stage of labour when compared to placebo. Further trials are needed to confirm its clinical role and safety. Its routine use cannot be recommended based on a single small study. There is no evidence available for other types of tocolytics.
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http://dx.doi.org/10.1002/14651858.CD007708.pub2DOI Listing
January 2011

Cervical pessary for preventing preterm birth.

Cochrane Database Syst Rev 2010 Sep 8(9):CD007873. Epub 2010 Sep 8.

Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University Hospital, Assiut, Egypt, 71511.

Background: Preterm delivery is a major health problem and contributes to more than 50% of the overall perinatal mortality. Cervical incompetence is one of the common causes of preterm birth to which different management strategies have been tried including cervical cerclage. Cervical cerclage is an invasive technique that needs anaesthesia and may be associated with complications. Moreover, there is still a matter of controversy regarding the efficacy and the group of patients which could benefit from this operation. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation.

Objectives: To evaluate the efficacy of cervical pessary for prevention of preterm birth in women with cervical incompetence.

Search Strategy: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2010), Current Controlled Trials and the Australian New Zealand Clinical Trials Registry (May 2010).

Selection Criteria: We selected all published and unpublished randomised clinical trials comparing the use of cervical pessary with cervical cerclage or expectant management for prevention of preterm birth. We did not include quasi-randomised trials, cluster-randomised and crossover trials.

Data Collection And Analysis: Two review authors independently assessed trials for inclusion.

Main Results: The search identified two trials which we excluded. Three additional trials are ongoing. This review contains no included studies.

Authors' Conclusions: The review did not identify any well-designed randomised clinical trial in order to confirm or refute the benefit of cervical pessary. However, there is evidence from non-randomised trials that showed some benefit of cervical pessary in preventing preterm birth. We are waiting for the results of three ongoing randomised controlled trials, assessing the role of cervical pessary in women with short cervix. There is a need for further well-designed randomised controlled trials.
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September 2010

Uterine massage to reduce postpartum hemorrhage after vaginal delivery.

Int J Gynaecol Obstet 2010 Oct;111(1):32-6

Department of Obstetrics and Gynecology, Women's Health Centre, Assiut University Hospital, Assiut, Egypt.

Objective: To determine the effectiveness of sustained uterine massage started before delivery of the placenta in reducing postpartum hemorrhage.

Methods: A randomized controlled trial conducted in Egypt and South Africa between September 2006 and February 2009. A total of 1964 pregnant women were randomly allocated to 1 of 3 treatment groups: intramuscular oxytocin, sustained uterine massage, or both treatments. Blood loss within 30 minutes of delivery was recorded.

Results: The incidence of blood loss of 300 mL or more within 30 minutes of delivery was significantly higher in the massage group than in the massage plus oxytocin (RR 1.88; 95% CI, 1.29-2.74 in Assiut, and RR 1.3; 95% CI, 1.00-1.68 in SA) and the oxytocin only group (RR 1.7; 95% CI, 1.11-2.61 in Assiut, and RR 2.24; 95% CI, 1.54-3.27 in SA). In both centers, use of additional uterotonics was significantly higher in the uterine massage group compared with the other 2 groups.

Conclusion: Uterine massage was less effective than oxytocin for reducing blood loss after delivery. When oxytocin was used, there was no additional benefit from uterine massage. The effectiveness of uterine massage in the absence of oxytocin was not studied. ACTRN: 12609000372280.
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October 2010

Misoprostol as an adjunct to standard uterotonics for treatment of post-partum haemorrhage: a multicentre, double-blind randomised trial.

Lancet 2010 May;375(9728):1808-13

UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, WHO, Geneva, Switzerland.

Background: Post-partum haemorrhage is a leading cause of global maternal morbidity and mortality. Misoprostol, a prostaglandin analogue with uterotonic activity, is an attractive option for treatment because it is stable, active orally, and inexpensive. We aimed to assess the effectiveness of misoprostol as an adjunct to standard uterotonics compared with standard uterotonics alone for treatment of post-partum haemorrhage.

Methods: Women delivering vaginally who had clinically diagnosed post-partum haemorrhage due to uterine atony were enrolled from participating hospitals in Argentina, Egypt, South Africa, Thailand, and Vietnam between July, 2005, and August, 2008. Computer-generated randomisation was used to assign women to receive 600 microg misoprostol or matching placebo sublingually; both groups were also given routine injectable uterotonics. Allocation was concealed by distribution of sealed and sequentially numbered treatment packs in the order that women were enrolled. Providers and women were masked to treatment assignment. The primary outcome was blood loss of 500 mL or more within 60 min after randomisation. Analysis was by intention to treat. This study is registered, number ISRCTN34455240.

Findings: 1422 women were assigned to receive misoprostol (n=705) or placebo (n=717). The proportion of women with blood loss of 500 mL or more within 60 min was similar between the misoprostol group (100 [14%]) and the placebo group (100 [14%]; relative risk 1.02, 95% CI 0.79-1.32). In the first 60 min, an increased proportion of women on misoprostol versus placebo, had shivering (455/704 [65%] vs 230/717 [32%]; 2.01, 1.79-2.27) and body temperature of 38 degrees C or higher (303/704 [43%] vs 107/717 [15%]; 2.88, 2.37-2.50).

Interpretation: Findings from this study do not support clinical use of 600 microg sublingual misoprostol in addition to standard injectable uterotonics for treatment of post-partum haemorrhage.

Funding: Bill & Melinda Gates Foundation, and UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.
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May 2010

Making stillbirths count, making numbers talk - issues in data collection for stillbirths.

BMC Pregnancy Childbirth 2009 Dec 17;9:58. Epub 2009 Dec 17.

Department of Genes and Environment, Division of Epidemiology, Norwegian Institute of Public Health, P.O. Box 4404 Nydalen, N-0403 Oslo, Norway.

Background: Stillbirths need to count. They constitute the majority of the world's perinatal deaths and yet, they are largely invisible. Simply counting stillbirths is only the first step in analysis and prevention. From a public health perspective, there is a need for information on timing and circumstances of death, associated conditions and underlying causes, and availability and quality of care. This information will guide efforts to prevent stillbirths and improve quality of care.

Discussion: In this report, we assess how different definitions and limits in registration affect data capture, and we discuss the specific challenges of stillbirth registration, with emphasis on implementation. We identify what data need to be captured, we suggest a dataset to cover core needs in registration and analysis of the different categories of stillbirths with causes and quality indicators, and we illustrate the experience in stillbirth registration from different cultural settings. Finally, we point out gaps that need attention in the International Classification of Diseases and review the qualities of alternative systems that have been tested in low- and middle-income settings.

Summary: Obtaining high-quality data will require consistent definitions for stillbirths, systematic population-based registration, better tools for surveys and verbal autopsies, capacity building and training in procedures to identify causes of death, locally adapted quality indicators, improved classification systems, and effective registration and reporting systems.
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http://dx.doi.org/10.1186/1471-2393-9-58DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2805601PMC
December 2009

Active management of the third stage of labour without controlled cord traction: a randomized non-inferiority controlled trial.

Reprod Health 2009 Jan 21;6. Epub 2009 Jan 21.

UNDP/UNFPA/WHO/World Bank Special Programme of Research, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Background: The third stage of labour refers to the period between birth of the baby and complete expulsion of the placenta. Some degree of blood loss occurs after the birth of the baby due to separation of the placenta. This period is a risky period because uterus may not contract well after birth and heavy blood loss can endanger the life of the mother. Active management of the third stage of labour (AMTSL) reduces the occurrence of severe postpartum haemorrhage by approximately 60-70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy it would have major implications for effective management of the third stage of labour at peripheral levels of health care.

Objective: The primary objective is to determine whether the simplified package of oxytocin 10 IU IM/IV is not less effective than the full AMTSL package.

Methods: A hospital-based, multicentre, individually randomized controlled trial is proposed. The hypothesis tested will be a non-inferiority hypothesis. The aim will be to determine whether the simplified package without CCT, with the advantage of not requiring training to acquire the manual skill to perform this task, is not less effective than the full AMTSL package with regard to reducing blood loss in the third stage of labour.The simplified package will include uterotonic (oxytocin 10 IU IM) injection after delivery of the baby and cord clamping and cutting at approximately 3 minutes after birth. The full package will include the uterotonic injection (oxytocin 10 IU IM), controlled cord traction following observation of uterine contraction and cord clamping and cutting at approximately 3 minutes after birth. The primary outcome measure is blood loss of 1000 ml or more at one hour and up to two hours for women who continue to bleed after one hour. The secondary outcomes are blood transfusion, the use of additional uterotonics and measure of severe morbidity and maternal death.We aim to recruit 25,000 women delivering vaginally in health facilities in eight countries within a 12 month recruitment period.

Management: Overall trial management will be from HRP/RHR in Geneva. There will be eight centres located in Argentina, Egypt, India, Kenya, Philippines, South Africa, Thailand and Uganda. There will be an online data entry system managed from HRP/RHR. The trial protocol was developed following a technical consultation with international organizations and leading researchers in the field.

Expected Outcomes: The main objective of this trial is to investigate whether a simplified package of third stage management can be recommended without increasing the risk of PPH. By avoiding the need for a manual procedure that requires training, the third stage management can be implemented in a more widespread and cost-effective way around the world even at the most peripheral levels of the health care system. This trial forms part of the programme of work to reduce maternal deaths due to postpartum haemorrhage within the RHR department in collaboration with other research groups and organizations active in the field.

Trial Registration: ACTRN12608000434392.
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http://dx.doi.org/10.1186/1742-4755-6-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2647525PMC
January 2009

The effect of calcium supplementation during pregnancy on fetal and infant growth: a nested randomized controlled trial within WHO calcium supplementation trial.

J Matern Fetal Neonatal Med 2009 Feb;22(2):94-100

Department of Obstetrics, Faculty of Medicine, Assiut University, Assiut, Egypt.

Objective: To evaluate whether prenatal calcium supplementation affects fetal and infant growth during the first year of life.

Methods: Ninety-one pregnant women and 159 mothers and their infants enrolled beginning before 20 weeks gestation, and women received daily supplements containing either 1.5 g calcium or placebo. Women were examined by ultrasound at 20, 24, 28, 32 and 36 weeks to evaluate fetal biometry. During the first year after delivery, sub-groups of infants born from mothers participating in the trial were examined to assess infant growth. Anthropometric measurements of the infants were assessed. Mothers were inquired about lactation patterns, morbidities of the infants, separation from the mother, and admission to hospital.

Results: Ultrasound measurements of fetal biometry did not show any differences between fetuses whose mothers received calcium supplementation during pregnancy and those who received placebo. Concerning infant growth, the mean weight and head circumference of infants born to calcium-supplemented mothers were similar to those born to placebo-supplemented mothers during the first year of life. The mean mid-arm circumference and mean length were significantly higher in the infants of the calcium group at sixth and ninth month, respectively. But, at 12 months, there were no significant differences in any of the anthropometric measurements.

Conclusion: Calcium supplementation during pregnancy of women with low calcium intake does not have a noticeable impact on fetal and infant growth during the first year of life.
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February 2009

Uterine massage for preventing postpartum haemorrhage.

Cochrane Database Syst Rev 2008 Jul 16(3):CD006431. Epub 2008 Jul 16.

Department of Obstetrics and Gynaecology, East London Hospital Complex, University of the Witwatersrand, University of Fort Hare, Eastern Cape Department of Health, East London, South Africa.

Background: Postpartum haemorrhage (PPH) (bleeding from the genital tract after childbirth) is a major cause of maternal mortality and disability, particularly in under-resourced areas. In these settings, poor nutrition, malaria and anaemia may aggravate the effects of PPH. In addition to the standard known strategies to prevent and treat PPH, there is a need for simple, non-expensive techniques which can be applied in low-resourced settings to prevent or treat PPH.

Objectives: To determine the effectiveness of uterine massage after birth and before or after delivery of the placenta, or both, to reduce postpartum blood loss and associated morbidity and mortality.

Search Strategy: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2008), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2007, Issue 2) and PubMed (1966 to June 2007).

Selection Criteria: All published, unpublished and ongoing randomised controlled trials comparing uterine massage alone or in addition to uterotonics before or after delivery of the placenta, or both, to non-massage.

Data Collection And Analysis: Both authors extracted the data independently using the agreed form.

Main Results: One randomised controlled trial in which 200 women were randomised to receive uterine massage or no massage after active management of the third stage of labour. The numbers of women with blood loss more than 500 ml was small, with wide confidence intervals and no statistically significant difference (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.16 to 1.67). There were no cases of retained placenta in either group. The mean blood loss was less in the uterine massage group at 30 minutes (mean difference (MD) -41.60, 95% CI -75.16 to -8.04) and 60 minutes after enrolment (MD -77.40, 95% CI -118.71 to -36.09 ml) . The need for additional uterotonics was reduced in the uterine massage group (RR 0.20, 95% CI 0.08 to 0.50). Two blood transfusions were administered in the control group.

Authors' Conclusions: The present review adds support to the 2004 joint statement of the International Confederation of Midwives and the International Federation of Gynaecologists and Obstetricians on the management of the third stage of labour, that uterine massage after delivery of the placenta is advised to prevent PPH. However, due to the limitations of the one trial reviewed, trials with sufficient numbers to estimate the effects of sustained uterine massage with great precision, both with and in the absence of uterotonics, are needed.
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http://dx.doi.org/10.1002/14651858.CD006431.pub2DOI Listing
July 2008

Blood pressure dynamics during pregnancy and spontaneous preterm birth.

Am J Obstet Gynecol 2007 Aug;197(2):162.e1-6

Division of Epidemiology, Statistics and Prevention Research, National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA.

Objective: The objective of the study was to examine whether blood pressure in early pregnancy and its rise in the second half of gestation are associated with spontaneous preterm birth in healthy, normotensive, nulliparous women.

Study Design: We included 5167 women with singleton gestation who participated in the World Health Organization Calcium Supplementation for the Prevention of Preeclampsia Trial. Systolic, diastolic, and mean arterial blood pressure and pulse pressure at baseline (12-19 weeks of gestation) and at the midthird trimester (30-34 weeks) were calculated. Rise in blood pressure was the difference between the midthird trimester and baseline. Preterm birth was defined as early preterm (less than 34 completed weeks) and late preterm birth (34-36 weeks).

Results: Women experiencing early or late preterm birth had over 10 mm Hg and 3 mm Hg higher rise, respectively, in systolic, diastolic, and mean arterial blood pressure than women delivering at term. A rise in systolic pressure over 30 mm Hg or diastolic pressure over 15 mm Hg was associated with a statistically significant 2- to 3-fold increase in risk of spontaneous preterm birth.

Conclusion: An excessive rise in either systolic or diastolic blood pressures from early pregnancy to the midthird trimester is associated with spontaneous preterm birth in a dose-response pattern.
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http://dx.doi.org/10.1016/j.ajog.2007.03.053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2033381PMC
August 2007

Causes of stillbirths and early neonatal deaths: data from 7993 pregnancies in six developing countries.

Bull World Health Organ 2006 Sep;84(9):699-705

Hung Vuong Hospital, 128 Hungvuong Street, 105 Ho Chi Minh City, Viet Nam.

Objective: To report stillbirth and early neonatal mortality and to quantify the relative importance of different primary obstetric causes of perinatal mortality in 171 perinatal deaths from 7993 pregnancies that ended after 28 weeks in nulliparous women.

Methods: A review of all stillbirths and early newborn deaths reported in the WHO calcium supplementation trial for the prevention of pre-eclampsia conducted at seven WHO collaborating centres in Argentina, Egypt, India, Peru, South Africa and Viet Nam. We used the Baird-Pattinson system to assign primary obstetric causes of death and classified causes of early neonatal death using the International classification of diseases and related health problems, Tenth revision (ICD-10).

Findings: Stillbirth rate was 12.5 per 1000 births and early neonatal mortality rate was 9.0 per 1000 live births. Spontaneous preterm delivery and hypertensive disorders were the most common obstetric events leading to perinatal deaths (28.7% and 23.6%, respectively). Prematurity was the main cause of early neonatal deaths (62%).

Conclusions: Advancements in the care of premature infants and prevention of spontaneous preterm labour and hypertensive disorders of pregnancy could lead to a substantial decrease in perinatal mortality in hospital settings in developing countries.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2627466PMC
http://dx.doi.org/10.2471/blt.05.027300DOI Listing
September 2006

Prevention of postpartum hemorrhage in the absence of uterotonics.

Int J Gynaecol Obstet 2006 Nov;94 Suppl 2:S124-S125

Department of Obstetrics and Gynecolosy, Assiut University Hospital, Assiut, Egypt.

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http://dx.doi.org/10.1016/S0020-7292(06)60005-2DOI Listing
November 2006

World Health Organization randomized trial of calcium supplementation among low calcium intake pregnant women.

Am J Obstet Gynecol 2006 Mar;194(3):639-49

Development Programme/United Nations Population Fund/World Health Organization/World Bank Special Programme of Research, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Objective: The purpose of this trial was to determine whether calcium supplementation of pregnant women with low calcium intake reduces preeclampsia and preterm delivery.

Study Design: Randomized placebo-controlled, double-blinded trial in nulliparous normotensive women from populations with dietary calcium < 600 mg/d. Women who were recruited before gestational week 20 received supplements (1.5 g calcium/d or placebo) throughout pregnancy. Primary outcomes were preeclampsia and preterm delivery; secondary outcomes focused on severe morbidity and maternal and neonatal mortality rates.

Results: The groups comprised 8325 women who were assigned randomly. Both groups had similar gestational ages, demographic characteristics, and blood pressure levels at entry. Compliance were both 85% and follow-up losses (calcium, 3.4%; placebo, 3.7%). Calcium supplementation was associated with a non-statistically significant small reduction in preeclampsia (4.1% vs 4.5%) that was evident by 35 weeks of gestation (1.2% vs 2.8%; P = .04). Eclampsia (risk ratio, 0.68: 95% CI, 0.48-0.97) and severe gestational hypertension (risk ratio, 0.71; 95% CI, 0.61-0.82) were significantly lower in the calcium group. Overall, there was a reduction in the severe preeclamptic complications index (risk ratio, 0.76; 95% CI, 0.66-0.89; life-table analysis, log rank test; P = .04). The severe maternal morbidity and mortality index was also reduced in the supplementation group (risk ratio, 0.80; 95% CI, 0.70-0.91). Preterm delivery (the neonatal primary outcome) and early preterm delivery tended to be reduced among women who were < or = 20 years of age (risk ratio, 0.82; 95% CI, 0.67-1.01; risk ratio, 0.64; 95% CI, 0.42-0.98, respectively). The neonatal mortality rate was lower (risk ratio, 0.70; 95% CI, 0.56-0.88) in the calcium group.

Conclusion: A 1.5-g calcium/day supplement did not prevent preeclampsia but did reduce its severity, maternal morbidity, and neonatal mortality, albeit these were secondary outcomes.
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http://dx.doi.org/10.1016/j.ajog.2006.01.068DOI Listing
March 2006

Tamoxifen treatment of bleeding irregularities associated with Norplant use.

Contraception 2005 Dec 9;72(6):432-7. Epub 2005 Aug 9.

Department of Obstetrics and Gynecology, Assiut University Hospital, Assiut 71511, Egypt.

Objectives: To evaluate the possible role of tamoxifen (selective estrogen receptor modulators, SERM) in treating bleeding irregularities associated with Norplant contraceptive use.

Material And Methods: Randomized clinical trial including 100 Norplant users complaining of vaginal bleeding irregularities. The trial was conducted in the Family Planning Clinic of Assiut University Hospital. Women were assigned at random to receive tamoxifen tablets (10 mg) twice daily for 10 days or similar placebo. Women were followed-up for 3 months. The end points were percentage of women who stopped bleeding during treatment, bleeding/spotting days during the period of follow-up, effect of treatment on their lifestyle, and side effects and discontinuation of contraception.

Results: There was good compliance with treatment. At the end of treatment, a significantly higher percentage of tamoxifen users stopped bleeding in comparison to the control group (88% vs. 68%, respectively; p=.016). Women who used tamoxifen had significantly less bleeding and/or spotting days than women who used placebo, during the first and second months. During the third month, there were no significant differences between the two groups. Women who used tamoxifen reported improvement in performing household activities, religious duties and in sexual life, during the first 2 months. In the third month, there were no differences between the two groups. There were no significant differences between tamoxifen and placebo groups in reporting side effects. In the group who used tamoxifen, two women discontinued Norplant use because of bleeding vs. nine women in the placebo group.

Conclusion: Tamoxifen use at a dose of 10 mg twice daily orally, for 10 days, has a beneficial effect on vaginal bleeding associated with Norplant use. In addition, the bleeding pattern was better in women who used tamoxifen for the following 2 months after treatment. However, these results have to be confirmed in a larger trial before advocating this line of treatment.
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http://dx.doi.org/10.1016/j.contraception.2005.05.015DOI Listing
December 2005