Publications by authors named "A Metin Gülmezoglu"

332 Publications

Correction to: Cost of hospital care of women with postpartum haemorrhage in India, Kenya, Nigeria and Uganda: a financial case for improved prevention.

Reprod Health 2021 Mar 6;18(1):57. Epub 2021 Mar 6.

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

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http://dx.doi.org/10.1186/s12978-021-01110-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937310PMC
March 2021

Mobile apps for detecting falsified and substandard drugs: A systematic review.

PLoS One 2021 4;16(2):e0246061. Epub 2021 Feb 4.

Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.

The use of substandard and counterfeit medicines (SCM) leads to significant health and economic consequences, like treatment failure, rise of antimicrobial resistance, extra expenditures of individuals or households and serious adverse drug reactions including death. Our objective was to systematically search, identify and compare relevant available mobile applications (apps) for smartphones and tablets, which use could potentially affect clinical and public health outcomes. We carried out a systematic review of the literature in January 2020, including major medical databases, and app stores. We used the validated Mobile App Rating Scale (MARS) to assess the quality of apps, (1 worst score, 3 acceptable score, and 5 best score). We planned to evaluate the accuracy of the mobile apps to detect SCM. We retrieved 335 references through medical databases and 42 from Apple, Google stores and Google Scholar. We finally included two studies of the medical database, 25 apps (eight from the App Store, eight from Google Play, eight from both stores, and one from Google Scholar), and 16 websites. We only found one report on the accuracy of a mobile apps detecting SCMs. Most apps use the imprint, color or shape for pill identification, and only a few offer pill detection through photographs or bar code. The MARS mean score for the apps was 3.17 (acceptable), with a maximum of 4.9 and a minimum of 1.1. The 'functionality' dimension resulted in the highest mean score (3.4), while the 'engagement' and 'information' dimensions showed the lowest one (3.0). In conclusion, we found a remarkable evidence gap about the accuracy of mobile apps in detecting SCMs. However, mobile apps could potentially be useful to screen for SCM by assessing the physical characteristics of pills, although this should still be assessed in properly designed research studies.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0246061PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7861418PMC
February 2021

Understanding abortion-related complications in health facilities: results from WHO multicountry survey on abortion (MCS-A) across 11 sub-Saharan African countries.

BMJ Glob Health 2021 Jan;6(1)

UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and ResearchTraining in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Introduction: Complications due to unsafe abortions are an important cause of morbidity and mortality in many sub-Saharan African countries. We aimed to characterise abortion-related complication severity, describe their management, and to report women's experience of abortion care in Africa.

Methods: A cross-sectional study was implemented in 210 health facilities across 11 sub-Saharan African countries. Data were collected on women's characteristics, clinical information and women's experience of abortion care (using the audio computer-assisted self-interviewing (ACASI) system). Severity of abortion complications were organised in five hierarchical mutually exclusive categories based on indicators present at assessment. Descriptive bivariate analysis was performed for women's characteristics, management of complications and reported experiences of abortion care by severity. Generalised linear estimation models were used to assess the association between women's characteristics and severity of complications.

Results: There were 13 657 women who had an abortion-related complication: 323 (2.4%) women were classified with severe maternal outcomes, 957 (7.0%) had potentially life-threatening complications, 7953 (58.2%) had moderate complications and 4424 (32.4%) women had mild complications. Women who were single, multiparous, presenting ≥13 weeks of gestational age and where expulsion of products of conception occurred prior to arrival to facility were more likely to experience severe complications. For management, the commonly used mechanical methods of uterine evacuation were manual vacuum aspiration (76.9%), followed by dilation and curettage (D&C) (20.1%). Most frequently used uterotonics were oxytocin (50∙9%) and misoprostol (22.7%). Via ACASI, 602 (19.5%) women reported having an induced abortion. Of those, misoprostol was the most commonly reported method (54.3%).

Conclusion: There is a critical need to increase access to and quality of evidence-based safe abortion, postabortion care and to improve understanding around women's experiences of abortion care.
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http://dx.doi.org/10.1136/bmjgh-2020-003702DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845704PMC
January 2021

Cost of hospital care of women with postpartum haemorrhage in India, Kenya, Nigeria and Uganda: a financial case for improved prevention.

Reprod Health 2021 Jan 22;18(1):18. Epub 2021 Jan 22.

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, 1201, Geneva, Switzerland.

Objective: Access to quality, effective lifesaving uterotonics in low and middle-income countries (LMICs) remains a major barrier to reducing maternal deaths from postpartum haemorrhage (PPH). Our objective was to assess the costs of care for women who receive different preventative uterotonics, and with PPH and no-PPH so that the differences, if significant, can inform better resource allocation for maternal health care.

Methods: The costs of direct hospital care of women who received oxytocin or heat-stable carbetocin for prevention of PPH in selected tertiary care facilities in India, Kenya, Nigeria, and Uganda were assessed. We collected data from all women who had PPH, as well as a random sample of women without PPH. Cost data was collected for the cost of stay, PPH interventions, transfusions and medications for 2966 women. We analyzed the difference in cost of care at a facility level between women who experienced a PPH event and those who did not. Key findings The mean cost of care of a woman experiencing PPH in the study sites in India, Kenya, Nigeria, and Uganda exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries.

Conclusion: Our results quantify the increased cost of PPH of up to 4.1 times that for a birth without PPH. PPH cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on uterotonics for the prevention of PPH or other interventions used to treat PPH. Trial registration HRP Trial A65870; UTN U1111-1162-8519; ACTRN12614000870651; CTRI/2016/05/006969, EUDRACT 2014-004445-26. Date of registration 14 August 2014 Access to quality, effective lifesaving medicines in low and middle-income countries remains a major barrier to reducing maternal deaths from bleeding after childbirth. Information on to what extent treatments for bleeding increases the cost of care of women after childbirth is important for informed resource allocation. We collected data from all women who had bleeding after childbirth, as well as a random sample of women without bleeding in selected hospitals in India, Kenya, Nigeria, and Uganda. Cost data was collected for the cost of stay and interventions to manage bleeding for 2966 women. We compared the difference in cost of care between women who experienced a bleeding event and those who did not. The mean cost of care of a woman with bleeding in the study sites exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. Our results indicate an increased cost of bleeding of up to 4.1 times that for birth without bleeding. Effective prevention reduces the cost of care. Cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on medications for the prevention of bleeding after childbirth or other interventions used to treat bleeding.
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http://dx.doi.org/10.1186/s12978-020-01063-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821537PMC
January 2021

Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis.

Cochrane Database Syst Rev 2020 11 24;11:CD012754. Epub 2020 Nov 24.

WHO Collaborating Centre for Global Women's Health Research, Institute of Metabolism and Systems Research, School of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.

Background: Postpartum haemorrhage (PPH), defined as a blood loss of 500 mL or more after birth, is the leading cause of maternal death worldwide. The World Health Organization (WHO) recommends that all women giving birth should receive a prophylactic uterotonic agent. Despite the routine administration of a uterotonic agent for prevention, PPH remains a common complication causing one-quarter of all maternal deaths globally. When prevention fails and PPH occurs, further administration of uterotonic agents as 'first-line' treatment is recommended. However, there is uncertainty about which uterotonic agent is best for the 'first-line' treatment of PPH.

Objectives: To identify the most effective uterotonic agent(s) with the least side-effects for PPH treatment, and generate a meaningful ranking among all available agents according to their relative effectiveness and side-effect profile.

Search Methods: We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (5 May 2020), and the reference lists of all retrieved studies.

Selection Criteria: All randomised controlled trials or cluster-randomised trials comparing the effectiveness and safety of uterotonic agents with other uterotonic agents for the treatment of PPH were eligible for inclusion.

Data Collection And Analysis: Two review authors independently assessed all trials for inclusion, extracted data and assessed each trial for risk of bias. Our primary outcomes were additional blood loss of 500 mL or more after recruitment to the trial until cessation of active bleeding and the composite outcome of maternal death or severe morbidity. Secondary outcomes included blood loss-related outcomes, morbidity outcomes, and patient-reported outcomes. We performed pairwise meta-analyses and indirect comparisons, where possible, but due to the limited number of included studies, we were unable to conduct the planned network meta-analysis. We used the GRADE approach to assess the certainty of evidence.

Main Results: Seven trials, involving 3738 women in 10 countries, were included in this review. All trials were conducted in hospital settings. Randomised women gave birth vaginally, except in one small trial, where women gave birth either vaginally or by caesarean section. Across the seven trials (14 trial arms) the following agents were used: six trial arms used oxytocin alone; four trial arms used misoprostol plus oxytocin; three trial arms used misoprostol; one trial arm used Syntometrine® (oxytocin and ergometrine fixed-dose combination) plus oxytocin infusion. Pairwise meta-analysis of two trials (1787 participants), suggests that misoprostol, as first-line treatment uterotonic agent, probably increases the risk of blood transfusion (risk ratio (RR) 1.47, 95% confidence interval (CI) 1.02 to 2.14, moderate-certainty) compared with oxytocin. Low-certainty evidence suggests that misoprostol administration may increase the incidence of additional blood loss of 1000 mL or more (RR 2.57, 95% CI 1.00 to 6.64). The data comparing misoprostol with oxytocin is imprecise, with a wide range of treatment effects for the additional blood loss of 500 mL or more (RR 1.66, 95% CI 0.69 to 4.02, low-certainty), maternal death or severe morbidity (RR 1.98, 95% CI 0.36 to 10.72, low-certainty, based on one study n = 809 participants, as the second study had zero events), and the use of additional uterotonics (RR 1.30, 95% CI 0.57 to 2.94, low-certainty). The risk of side-effects may be increased with the use of misoprostol compared with oxytocin: vomiting (2 trials, 1787 participants, RR 2.47, 95% CI 1.37 to 4.47, high-certainty) and fever (2 trials, 1787 participants, RR 3.43, 95% CI 0.65 to 18.18, low-certainty). According to pairwise meta-analysis of four trials (1881 participants) generating high-certainty evidence, misoprostol plus oxytocin makes little or no difference to the use of additional uterotonics (RR 0.99, 95% CI 0.94 to 1.05) and to blood transfusion (RR 0.95, 95% CI 0.77 to 1.17) compared with oxytocin. We cannot rule out an important benefit of using the misoprostol plus oxytocin combination over oxytocin alone, for additional blood loss of 500 mL or more (RR 0.84, 95% CI 0.66 to 1.06, moderate-certainty). We also cannot rule out important benefits or harms for additional blood loss of 1000 mL or more (RR 0.76, 95% CI 0.43 to 1.34, moderate-certainty, 3 trials, 1814 participants, one study reported zero events), and maternal mortality or severe morbidity (RR 1.09, 95% CI 0.35 to 3.39, moderate-certainty). Misoprostol plus oxytocin increases the incidence of fever (4 trials, 1866 participants, RR 3.07, 95% CI 2.62 to 3.61, high-certainty), and vomiting (2 trials, 1482 participants, RR 1.85, 95% CI 1.16 to 2.95, high-certainty) compared with oxytocin alone. For all outcomes of interest, the available evidence on the misoprostol versus Syntometrine® plus oxytocin combination was of very low-certainty and these effects remain unclear. Although network meta-analysis was not performed, we were able to compare the misoprostol plus oxytocin combination with misoprostol alone through the common comparator of oxytocin. This indirect comparison suggests that the misoprostol plus oxytocin combination probably reduces the risk of blood transfusion (RR 0.65, 95% CI 0.42 to 0.99, moderate-certainty) and may reduce the risk of additional blood loss of 1000 mL or more (RR 0.30, 95% CI 0.10 to 0.89, low-certainty) compared with misoprostol alone. The combination makes little or no difference to vomiting (RR 0.75, 95% CI 0.35 to 1.59, high-certainty) compared with misoprostol alone. Misoprostol plus oxytocin compared to misoprostol alone are compatible with a wide range of treatment effects for additional blood loss of 500 mL or more (RR 0.51, 95% CI 0.20 to 1.26, low-certainty), maternal mortality or severe morbidity (RR 0.55, 95% CI 0.07 to 4.24, low-certainty), use of additional uterotonics (RR 0.76, 95% CI 0.33 to 1.73, low-certainty), and fever (RR 0.90, 95% CI 0.17 to 4.77, low-certainty).

Authors' Conclusions: The available evidence suggests that oxytocin used as first-line treatment of PPH probably is more effective than misoprostol with less side-effects. Adding misoprostol to the conventional treatment of oxytocin probably makes little or no difference to effectiveness outcomes, and is also associated with more side-effects. The evidence for most uterotonic agents used as first-line treatment of PPH is limited, with no evidence found for commonly used agents, such as injectable prostaglandins, ergometrine, and Syntometrine®.
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http://dx.doi.org/10.1002/14651858.CD012754.pub2DOI Listing
November 2020

The first 2 h after birth: prevalence and factors associated with neonatal care practices from a multicountry, facility-based, observational study.

Lancet Glob Health 2021 01 12;9(1):e72-e80. Epub 2020 Nov 12.

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

Background: Amid efforts to improve the quality of care for women and neonates during childbirth, there is growing interest in the experience of care, including respectful care practices. However, there is little research on the prevalence of practices that might constitute mistreatment of neonates. This study aims to describe the care received by neonates up to 2 h after birth in a sample of three countries in west Africa.

Methods: Data from this multicountry, facility-based, observational study were collected on 15 neonatal care practices across nine facilities in Ghana, Guinea, and Nigeria, as part of WHO's wider multicountry study on how women are treated during childbirth. Women were eligible if they were admitted to the participating health facilities for childbirth, in early established labour or active labour, aged 15 years or older, and provided written informed consent on behalf of themselves and their neonate. All labour observations were continuous, one-to-one observations of women and neonates by independent data collectors. Descriptive statistics and multivariate logistic regressions were used to examine associations between these neonatal care practices, maternal and neonate characteristics, and maternal mistreatment. Early neonate deaths, stillbirths, and higher order multiple births were excluded from analysis.

Findings: Data collection took place from Sept 19, 2016, to Feb 26, 2017, in Nigeria; from Aug 1, 2017, to Jan 18, 2018, in Ghana; and from July 1 to Oct 30, 2017, in Guinea. We included data for 362 women-neonate dyads (356 [98%] with available data for neonatal care practices) in Nigeria, 760 (749 [99%]) in Ghana, and 558 (522 [94%]) in Guinea. Delayed cord clamping was done for most neonates (1493 [91·8%] of 1627); other practices, such as skin-to-skin contact, were less commonly done (1048 [64·4%]). During the first 2 h after birth, separation of the mother and neonate occurred in 844 (51·9%) of 1627 cases; and was more common for mothers who were single (adjusted odds ratio [AOR; adjusting for country, maternal age, education, marital status, neonate weight at birth, and neonate sex] 1·8, 95% CI 1·3-2·6) than those who were married or cohabiting. Lack of maternal education was associated with increased likelihood of neonates not receiving recommended breastfeeding practices. Neonates with a low birthweight (<2·5 kg) were more likely (1·7, 1·1-2·8) to not begin breastfeeding on demand than full weight neonates. When women experienced physical abuse from providers within 1 h before childbirth, their neonates were more likely to be slapped (AOR 1·9, 1·1-3·9).

Interpretation: A high proportion of neonates did not receive recommended care practices, and some received practices that might constitute mistreatment. Further research is needed on understanding and measuring mistreatment to improve care, including respectful care, for mothers and neonates.

Funding: US Agency for International Development, and the UNDP/UN Population Fund/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, WHO.
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http://dx.doi.org/10.1016/S2214-109X(20)30422-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7790760PMC
January 2021

Risk factors associated with adverse maternal outcomes following intrapartum cesarean birth: a secondary analysis of the WHO global survey on maternal and perinatal health, 2004-2008.

BMC Pregnancy Childbirth 2020 Nov 11;20(1):687. Epub 2020 Nov 11.

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

Background: To identify risk factors associated with a composite adverse maternal outcomes in women undergoing intrapartum cesarean birth.

Methods: We used the facility-based, multi-country, cross-sectional WHO Global Survey of Maternal and Perinatal Health (2004-2008) to examine associations between woman-, labor/obstetric-, and facility-level characteristics and a composite adverse maternal outcome of postpartum morbidity and mortality. This analysis was performed among women who underwent intrapartum cesarean birth during the course of labor.

Results: We analyzed outcomes of 29,516 women from low- and middle-income countries who underwent intrapartum cesarean birth between the gestational ages of 24 and 43 weeks, 3.5% (1040) of whom experienced the composite adverse maternal outcome. In adjusted analyses, factors associated with a decreased risk of the adverse maternal outcome associated with intrapartum cesarean birth included having four or more antenatal visits (AOR 0.60; 95% CI: 0.43-0.84; p = 0.003), delivering in a medium- or high-human development index country (vs. low-human development index country: AOR 0.07; 95% CI: 0.01-0.85 and AOR 0.02; 95% CI: 0.001-0.39, respectively; p = 0.03), and malpresentation (vs. cephalic: breech AOR 0.52; CI: 0.31-0.87; p = 0.04). Women who were medically high risk (vs. not medically high risk: AOR 1.81; CI: 1.30-2.51, p < 0.0004), had less education (0-6 years) (vs. 13+ years; AOR 1.64; CI: 1.03-2.63; p = 0.01), were obstetrically high risk (vs. not high risk; AOR 3.67; CI: 2.58-5.23; p < 0.0001), or had a maternal or obstetric indication (vs. elective: AOR 4.74; CI: 2.36-9.50; p < 0.0001) had increased odds of the adverse outcome.

Conclusion: We found reduced adverse maternal outcomes of intrapartum cesarean birth in women with ≥ 4 antenatal visits, those who delivered in a medium or high human development index country, and those with malpresenting fetuses. Maternal adverse outcomes associated with intrapartum cesarean birth were medically and obstetrically high risk women, those with less education, and those with a maternal or obstetric indication for intrapartum cesarean birth.
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http://dx.doi.org/10.1186/s12884-020-03390-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7659204PMC
November 2020

Cost of goods sold analysis and recommendations to reduce costs of co-packaged mifepristone-misoprostol for medical abortion.

Reprod Health 2020 Nov 4;17(1):171. Epub 2020 Nov 4.

Concept Foundation, Avenue de Sécheron 15, 1202, Geneva, Switzerland.

Objective: Understanding the price components of the mifepristone/misoprostol (combi-pack) for medical abortion to improve access is critical for identifying strategies to reduce product costs for quality-assured formulations and expanding its availability and use.

Methods: We constructed a cost of goods sold analysis using data collected from manufacturing companies in Bangladesh, China and India supported by publicly available information related to the product formulation, active pharmaceutical ingredients (API), manufacturing location, manufacturer profiles and other individual model components. Key model components were the active pharmaceutical ingredients (quality-assured or not), excipients, labour cost, operating cost and packaging.

Results: Combi-pack direct production cost ranges from US$1.08 for finished products which are not quality assured to US$3.05 for products containing quality assured active pharmaceutical ingredients, which means that with a 30% administrative fee applied to those prices, it could be made available between US$1.40 and US$3.97 depending on location, manufacturer's profile, optimal market situation and the quality of the active pharmaceutical ingredients. The main model component impacting on the cost range is the purchase price of mifepristone active pharmaceutical ingredient and the current differential between quality-assured material supported by adequate documentation and API for which quality assurance cannot be demonstrated. Compared to India cost of goods sold is lower in Bangladesh primarily due to lower operating costs, including the cost of labour.

Conclusions: It is feasible to lower the cost of quality-assured combi-packs, through reducing mifepristone API cost and selection of the manufacturing location. However, manufacturers need to be incentivised to achieve WHO pre-qualification with a carefully built business case and require support in identifying and sourcing competitively priced material and manufacturing products to the necessary standard.
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http://dx.doi.org/10.1186/s12978-020-01012-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640653PMC
November 2020

Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.

Authors:
Olufemi T Oladapo Joshua P Vogel Gilda Piaggio My-Huong Nguyen Fernando Althabe A Metin Gülmezoglu Rajiv Bahl Suman P N Rao Ayesha De Costa Shuchita Gupta Abdullah H Baqui Rasheda Khanam Mohammod Shahidullah Saleha B Chowdhury Salahuddin Ahmed Nazma Begum Arunangshu D Roy M A Shahed Iffat A Jaben Farida Yasmin M Mozibur Rahman Anjuman Ara Soofia Khatoon Gulshan Ara Shaheen Akter Nasreen Akhter Probhat R Dey M Abdus Sabur Mohammad T Azad Shahana F Choudhury M A Matin Shivaprasad S Goudar Sangappa M Dhaded Mrityunjay C Metgud Yeshita V Pujar Manjunath S Somannavar Sunil S Vernekar Veena R Herekar Shailaja R Bidri Sangamesh S Mathapati Preeti G Patil Mallanagouda M Patil Muttappa R Gudadinni Hidaytullah R Bijapure Ashalata A Mallapur Geetanjali M Katageri Sumangala B Chikkamath Bhuvaneshwari C Yelamali Ramesh R Pol Sujata S Misra Leena Das Saumya Nanda Rashmita B Nayak Bipsa Singh Zahida Qureshi Fredrick Were Alfred Osoti George Gwako Ahmed Laving John Kinuthia Hafsa Mohamed Nawal Aliyan Adelaide Barassa Elizabeth Kibaru Margaret Mbuga Lydia Thuranira Njoroge J Githua Bernadine Lusweti Adejumoke I Ayede Adegoke G Falade Olubukola A Adesina Atinuke M Agunloye Oluwatosin O Iyiola Wilfred Sanni Ifeyinwa K Ejinkeonye Hadiza A Idris Chinyere V Okoli Theresa A Irinyenikan Omolayo A Olubosede Olaseinde Bello Olufemi M Omololu Olanike A Olutekunbi Adesina L Akintan Olorunfemi O Owa Rosena O Oluwafemi Ireti P Eniowo Adetokunbo O Fabamwo Elizabeth A Disu Joy O Agbara Ebunoluwa A Adejuyigbe Oluwafemi Kuti Henry C Anyabolu Ibraheem O Awowole Akintunde O Fehintola Bankole P Kuti Anthony D Isah Eyinade K Olateju Olusanya Abiodun Olabisi F Dedeke Francis B Akinkunmi Lawal Oyeneyin Omotayo Adesiyun Hadijat O Raji Adedapo B A Ande Ikechukwu Okonkwo Shabina Ariff Sajid B Soofi Lumaan Sheikh Saima Zulfiqar Sadia Omer Raheel Sikandar Salma Sheikh Daniel Giordano Hugo Gamerro Guillermo Carroli Jose Carvalho James Neilson Elizabeth Molyneux Khalid Yunis Kidza Mugerwa Harish K Chellani

N Engl J Med 2020 12 23;383(26):2514-2525. Epub 2020 Oct 23.

The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).

Background: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain.

Methods: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale.

Results: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events.

Conclusions: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).
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http://dx.doi.org/10.1056/NEJMoa2022398DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660991PMC
December 2020

Analgesia for vaginal birth: Secondary analysis from the WHO Multicountry Survey on Maternal and Newborn Health.

Int J Gynaecol Obstet 2021 Mar 11;152(3):401-408. Epub 2020 Nov 11.

Department of Obstetrics and Gynaecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.

Objective: To evaluate the use of analgesia during labor in women who had a vaginal birth and to determine the factors associated with its use.

Methods: A secondary analysis was performed of the WHO Multicountry Survey on Maternal and Newborn Health, a cross-sectional, facility-based survey including 359 healthcare facilities in 29 countries. The prevalence of analgesia use for vaginal birth in different countries was reported according to the Human Development Index (HDI). Sociodemographic and obstetric characteristics of the participants with and without analgesia were compared. The prevalence ratios were compared across countries, HDI groups, and regions using a design-based χ test.

Results: Among the 221 345 women who had a vaginal birth, only 4% received labor analgesia, mainly epidural. The prevalence of women receiving analgesia was significantly higher in countries with a higher HDI than in countries with a lower HDI. Education was significantly associated with increased use of analgesia; nulliparous women and women undergoing previous cesarean delivery had a significantly increased likelihood of receiving analgesia.

Conclusion: Use of analgesia for women undergoing labor and vaginal delivery was low, specifically in low-HDI countries. Whether low use of analgesia reflects women's desire or an unmet need for pain relief requires further studies.
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http://dx.doi.org/10.1002/ijgo.13424DOI Listing
March 2021

Correction to: Self-care and remote care during pregnancy: a new paradigm?

Health Res Policy Syst 2020 Oct 12;18(1):119. Epub 2020 Oct 12.

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

An amendment to this paper has been published and can be accessed via the original article.
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http://dx.doi.org/10.1186/s12961-020-00641-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7552382PMC
October 2020

Self-care and remote care during pregnancy: a new paradigm?

Health Res Policy Syst 2020 Sep 18;18(1):107. Epub 2020 Sep 18.

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

Self-care interventions and remote care offer innovative and equitable ways to strengthen access to sexual and reproductive health services. Self-isolation during COVID-19 provided the opportunity for obstetric facilities and healthcare providers to integrate and increase the usage of interventions for self-care and remote care for pregnant women and to improve the quality of care overall.
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http://dx.doi.org/10.1186/s12961-020-00627-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499941PMC
September 2020

Mifepristone for emergency contraception: Case for recommendation in practice guidelines.

Contraception 2020 Dec 19;102(6):383-384. Epub 2020 Aug 19.

Concept Foundation, Batiment F2F3, Avenue de Sechéron, Geneva CH-1202, Switzerland. Electronic address:

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http://dx.doi.org/10.1016/j.contraception.2020.08.005DOI Listing
December 2020

Optimal intrapartum care in the twenty-first century.

Best Pract Res Clin Obstet Gynaecol 2020 Aug 2;67:1-3. Epub 2020 Jul 2.

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

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http://dx.doi.org/10.1016/j.bpobgyn.2020.06.009DOI Listing
August 2020

Non-clinical interventions to reduce unnecessary caesarean sections: WHO recommendations.

Bull World Health Organ 2020 Jan 29;98(1):66-68. Epub 2019 Nov 29.

UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, 1211 Geneva 27, Switzerland.

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http://dx.doi.org/10.2471/BLT.19.236729DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933434PMC
January 2020

Maternal characteristics and causes associated with refractory postpartum haemorrhage after vaginal birth: a secondary analysis of the WHO CHAMPION trial data.

BJOG 2020 Apr 8;127(5):628-634. Epub 2020 Jan 8.

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), Geneva, Switzerland.

Objective: To assess the maternal characteristics and causes associated with refractory postpartum haemorrhage (PPH).

Design: Secondary analysis of the WHO CHAMPION trial data.

Setting: Twenty-three hospitals in ten countries.

Population: Women from the CHAMPION trial who received uterotonics as first-line treatment of PPH.

Methods: We assessed the association between sociodemographic, pregnancy and childbirth factors and refractory PPH, and compared the causes of PPH between women with refractory PPH and women responsive to first-line PPH treatment.

Main Outcome Measures: Maternal characteristics; causes of PPH.

Results: Women with labour induced or augmented with uterotonics (adjusted odds ratio [aOR] 1.35; 95% CI 1.07-1.72), with episiotomy or tears requiring suturing (aOR 1.82; 95% CI 1.34-2.48) and who had babies with birthweights ≥3500 g (aOR 1.33; 95% CI 1.04-1.69) showed significantly higher odds of refractory PPH compared with the reference categories in the multivariate analysis adjusted by centre and trial arm. While atony was the sole PPH cause in 53.2% (116/218) of the women in the responsive PPH group, it accounted for only 31.5% (45/143) of the causes in the refractory PPH group. Conversely, tears were the sole cause in 12.8% (28/218) and 28% (40/143) of the responsive PPH and refractory PPH groups, respectively. Placental problems were the sole cause in 11 and 5.6% in the responsive and refractory PPH groups, respectively.

Conclusion: Women with refractory PPH showed a different pattern of maternal characteristics and PPH causes compared with those with first-line treatment responsive PPH.

Tweetable Abstract: Women with refractory postpartum haemorrhage are different from those with first-line treatment responsive PPH.
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http://dx.doi.org/10.1111/1471-0528.16040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7078998PMC
April 2020

Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation.

Int J Gynaecol Obstet 2020 Mar 23;148(3):290-299. Epub 2019 Dec 23.

Safe Motherhood Program, University of California, San Francisco, CA, USA.

Objective: To systematically develop evidence-based bundles for care of postpartum hemorrhage (PPH).

Methods: An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated "GRADE Evidence-to-Decision" framework. Twenty-three global maternal-health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6-month period, the expert panel met online and via teleconferences, culminating in a 2-day in-person meeting.

Results: The consultation led to the definition of two care bundles for facility implementation. The "first response to PPH bundle" comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The "response to refractory PPH bundle" comprises compressive measures (aortic or bimanual uterine compression), the non-pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements.

Conclusion: For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.
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http://dx.doi.org/10.1002/ijgo.13028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7064978PMC
March 2020

How women are treated during facility-based childbirth in four countries: a cross-sectional study with labour observations and community-based surveys.

Lancet 2019 11 8;394(10210):1750-1763. Epub 2019 Oct 8.

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: Women across the world are mistreated during childbirth. We aimed to develop and implement evidence-informed, validated tools to measure mistreatment during childbirth, and report results from a cross-sectional study in four low-income and middle-income countries.

Methods: We prospectively recruited women aged at least 15 years in twelve health facilities (three per country) in Ghana, Guinea, Myanmar, and Nigeria between Sept 19, 2016, and Jan 18, 2018. Continuous observations of labour and childbirth were done from admission up to 2 h post partum. Surveys were administered by interviewers in the community to women up to 8 weeks post partum. Labour observations were not done in Myanmar. Data were collected on sociodemographics, obstetric history, and experiences of mistreatment.

Findings: 2016 labour observations and 2672 surveys were done. 838 (41·6%) of 2016 observed women and 945 (35·4%) of 2672 surveyed women experienced physical or verbal abuse, or stigma or discrimination. Physical and verbal abuse peaked 30 min before birth until 15 min after birth (observation). Many women did not consent for episiotomy (observation: 190 [75·1%] of 253; survey: 295 [56·1%] of 526) or caesarean section (observation: 35 [13·4%] of 261; survey: 52 [10·8%] of 483), despite receiving these procedures. 133 (5·0%) of 2672 women or their babies were detained in the facility because they were unable to pay the bill (survey). Younger age (15-19 years) and lack of education were the primary determinants of mistreatment (survey). For example, younger women with no education (odds ratio [OR] 3·6, 95% CI 1·6-8·0) and younger women with some education (OR 1·6, 1·1-2·3) were more likely to experience verbal abuse, compared with older women (≥30 years), adjusting for marital status and parity.

Interpretation: More than a third of women experienced mistreatment and were particularly vulnerable around the time of birth. Women who were younger and less educated were most at risk, suggesting inequalities in how women are treated during childbirth. Understanding drivers and structural dimensions of mistreatment, including gender and social inequalities, is essential to ensure that interventions adequately account for the broader context.

Funding: United States Agency for International Development and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, WHO.
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http://dx.doi.org/10.1016/S0140-6736(19)31992-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6853169PMC
November 2019

Developing and applying a 'living guidelines' approach to WHO recommendations on maternal and perinatal health.

BMJ Glob Health 2019 19;4(4):e001683. Epub 2019 Aug 19.

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

How should the WHO most efficiently keep its global recommendations up to date? In this article we describe how WHO developed and applied a 'living guidelines' approach to its maternal and perinatal health (MPH) recommendations, based on a systematic and continuous process of prioritisation and updating. Using this approach, 25 new or updated WHO MPH recommendations have been published in 2017-2018. The new approach helps WHO ensure its guidance is responsive to emerging evidence and remains up to date for end users.
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http://dx.doi.org/10.1136/bmjgh-2019-001683DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6703290PMC
August 2019

Mode of delivery among nulliparous women with single, cephalic, term pregnancies: The WHO global survey on maternal and perinatal health, 2004-2008.

Int J Gynaecol Obstet 2019 Nov 29;147(2):165-172. Epub 2019 Aug 29.

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

Objective: To determine risk factors associated with cesarean delivery among nulliparous women in spontaneous labor with a single, cephalic, term pregnancy (Robson group 1).

Methods: Data were assessed from the WHO Global Survey of Maternal and Perinatal Health conducted in 2004-2008.

Results: Among 82 280 women in Robson group 1, 67 698 (82.3%) had vaginal and 14 578 (17.7%) had cesarean delivery. In adjusted analyses, maternal factors associated with cesarean included age older than 18 years, being overweight or obese, being married or cohabitating, attending four prenatal visits or more, and being medically high risk (P<0.001). Women who were obstetrically high risk, referred during labor, or at 39 gestational weeks or more were also more likely to undergo cesarean (all P<0.001). Facility-level factors associated with cesarean were availability of an anesthesia service 24/7, being a teaching facility, requirement of fees for cesarean, availability of electronic fetal monitoring, and having providers skilled in operative vaginal delivery (all P<0.01).

Conclusion: The analysis highlights the importance of maintaining a healthy pre-pregnancy and pregnancy weight, optimizing management of women with medical problems, and ensuring clear referral mechanisms for women with intrapartum complications. The association between fees and cesarean delivery warrants further exploration.
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http://dx.doi.org/10.1002/ijgo.12929DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6773492PMC
November 2019

Diagnostic accuracy of the partograph alert and action lines to predict adverse birth outcomes: a systematic review.

BJOG 2019 12 18;126(13):1524-1533. Epub 2019 Aug 18.

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

Background: There are questions about the use of the 'one-centimetre per hour rule' as a valid benchmark for assessing the adequacy of labour progress.

Objectives: To determine the accuracy of the alert (1-cm/hour) and action lines of the cervicograph in the partograph to predict adverse birth outcomes among women in first stage of labour.

Search Strategy: PubMed, EMBASE, CINAHL, POPLINE, Global Health Library, and reference lists of eligible studies.

Selection Criteria: Observational studies and other study designs reporting data on the correlation between the alert line status of women in labour and the occurrence of adverse birth outcomes.

Data Collection And Analysis: Two reviewers at a time independently identified eligible studies and independently abstracted data including population characteristics and maternal and perinatal outcomes.

Main Results: Thirteen studies in which 20 471 women participated were included in the review. The percentage of women crossing the alert line varied from 8 to 76% for all maternal or perinatal outcomes. No study showed a robust diagnostic test accuracy profile for any of the selected outcomes.

Conclusions: This systematic review does not support the use of the cervical dilatation over time (at a threshold of 1 cm/h during active first stage) to identify women at risk of adverse birth outcomes.

Tweetable Abstract: Alert line of partograph does not identify women at risk of adverse birth outcomes.
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http://dx.doi.org/10.1111/1471-0528.15884DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899985PMC
December 2019

Pregnancy outcomes of women with previous caesarean sections: Secondary analysis of World Health Organization Multicountry Survey on Maternal and Newborn Health.

Sci Rep 2019 07 5;9(1):9748. Epub 2019 Jul 5.

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

Secondary analysis of World Health Organization Multicountry Survey on Maternal and Newborn Health (WHOMCS) was undertaken among 173,124 multiparous women to assess the association between previous caesarean sections (CS) and pregnancy outcomes. Maternal outcomes included maternal near miss (MNM), maternal death (MD), severe maternal outcomes (SMO), abnormal placentation, and uterine rupture. Neonatal outcomes were stillbirth, early neonatal death, perinatal death, neonatal near miss (NNM), neonatal intensive care unit (NICU) admission, and preterm birth. Previous CS was associated with increased risks of uterine rupture (adjusted Odds Ratio (aOR); 7.74; 95% confidence interval (CI) 5.48, 10.92); morbidly adherent placenta (aOR 2.60; 95% CI 1.98, 3.40), MNM (aOR 1.91; 95% CI 1.59, 2.28), SMO (aOR 1.80; 95% CI 1.52, 2.13), placenta previa (aOR 1.76; 95% CI 1.49, 2.07). For neonatal outcomes, previous CS was associated with increased risks of NICU admission (aOR 1.31; 95% CI 1.23, 1.39), neonatal near miss (aOR 1.19; 95% CI 1.12, 1.26), preterm birth (aOR 1.07; 95% CI 1.01, 1.14), and decreased risk of macerated stillbirth (aOR 0.80; 95% CI 0.67, 0.95). Previous CS was associated with serious morbidity in future pregnancies. However, these findings should be cautiously interpreted due to lacking data on indications of previous CS.
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http://dx.doi.org/10.1038/s41598-019-46153-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6611838PMC
July 2019

Provision and uptake of routine antenatal services: a qualitative evidence synthesis.

Cochrane Database Syst Rev 2019 06 12;6:CD012392. Epub 2019 Jun 12.

Research in Childbirth and Health (ReaCH) unit, University of Central Lancashire, Preston, UK, PR1 2HE.

Background: Antenatal care (ANC) is a core component of maternity care. However, both quality of care provision and rates of attendance vary widely between and within countries. Qualitative research can assess factors underlying variation, including acceptability, feasibility, and the values and beliefs that frame provision and uptake of ANC programmes.This synthesis links to the Cochrane Reviews of the effectiveness of different antenatal models of care. It was designed to inform the World Health Organization guidelines for a positive pregnancy experience and to provide insights for the design and implementation of improved antenatal care in the future.

Objectives: To identify, appraise, and synthesise qualitative studies exploring:· Women's views and experiences of attending ANC; and factors influencing the uptake of ANC arising from women's accounts;· Healthcare providers' views and experiences of providing ANC; and factors influencing the provision of ANC arising from the accounts of healthcare providers.

Search Methods: To find primary studies we searched MEDLINE, Ovid; Embase, Ovid; CINAHL, EbscoHost; PsycINFO, EbscoHost; AMED, EbscoHost; LILACS, VHL; and African Journals Online (AJOL) from January 2000 to February 2019. We handsearched reference lists of included papers and checked the contents pages of 50 relevant journals through Zetoc alerts received during the searching phase.

Selection Criteria: We included studies that used qualitative methodology and that met our quality threshold; that explored the views and experiences of routine ANC among healthy, pregnant and postnatal women or among healthcare providers offering this care, including doctors, midwives, nurses, lay health workers and traditional birth attendants; and that took place in any setting where ANC was provided.We excluded studies of ANC programmes designed for women with specific complications. We also excluded studies of programmes that focused solely on antenatal education.

Data Collection And Analysis: Two authors undertook data extraction, logged study characteristics, and assessed study quality. We used meta-ethnographic and Framework techniques to code and categorise study data. We developed findings from the data and presented these in a 'Summary of Qualitative Findings' (SoQF) table. We assessed confidence in each finding using GRADE-CERQual. We used these findings to generate higher-level explanatory thematic domains. We then developed two lines of argument syntheses, one from service user data, and one from healthcare provider data. In addition, we mapped the findings to relevant Cochrane effectiveness reviews to assess how far review authors had taken account of behavioural and organisational factors in the design and implementation of the interventions they tested. We also translated the findings into logic models to explain full, partial and no uptake of ANC, using the theory of planned behaviour.

Main Results: We include 85 studies in our synthesis. Forty-six studies explored the views and experiences of healthy pregnant or postnatal women, 17 studies explored the views and experiences of healthcare providers and 22 studies incorporated the views of both women and healthcare providers. The studies took place in 41 countries, including eight high-income countries, 18 middle-income countries and 15 low-income countries, in rural, urban and semi-urban locations. We developed 52 findings in total and organised these into three thematic domains: socio-cultural context (11 findings, five moderate- or high-confidence); service design and provision (24 findings, 15 moderate- or high-confidence); and what matters to women and staff (17 findings, 11 moderate- or high-confidence) The third domain was sub-divided into two conceptual areas; personalised supportive care, and information and safety. We also developed two lines of argument, using high- or moderate-confidence findings:For women, initial or continued use of ANC depends on a perception that doing so will be a positive experience. This is a result of the provision of good-quality local services that are not dependent on the payment of informal fees and that include continuity of care that is authentically personalised, kind, caring, supportive, culturally sensitive, flexible, and respectful of women's need for privacy, and that allow staff to take the time needed to provide relevant support, information and clinical safety for the woman and the baby, as and when they need it. Women's perceptions of the value of ANC depend on their general beliefs about pregnancy as a healthy or a risky state, and on their reaction to being pregnant, as well as on local socio-cultural norms relating to the advantages or otherwise of antenatal care for healthy pregnancies, and for those with complications. Whether they continue to use ANC or not depends on their experience of ANC design and provision when they access it for the first time.The capacity of healthcare providers to deliver the kind of high-quality, relationship-based, locally accessible ANC that is likely to facilitate access by women depends on the provision of sufficient resources and staffing as well as the time to provide flexible personalised, private appointments that are not overloaded with organisational tasks. Such provision also depends on organisational norms and values that overtly value kind, caring staff who make effective, culturally-appropriate links with local communities, who respect women's belief that pregnancy is usually a normal life event, but who can recognise and respond to complications when they arise. Healthcare providers also require sufficient training and education to do their job well, as well as an adequate salary, so that they do not need to demand extra informal funds from women and families, to supplement their income, or to fund essential supplies.

Authors' Conclusions: This review has identified key barriers and facilitators to the uptake (or not) of ANC services by pregnant women, and in the provision (or not) of good-quality ANC by healthcare providers. It complements existing effectiveness reviews of models of ANC provision and adds essential insights into why a particular type of ANC provided in specific local contexts may or may not be acceptable, accessible, or valued by some pregnant women and their families/communities. Those providing and funding services should consider the three thematic domains identified by the review as a basis for service development and improvement. Such developments should include pregnant and postnatal women, community members and other relevant stakeholders.
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http://dx.doi.org/10.1002/14651858.CD012392.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6564082PMC
June 2019

Alternative Magnesium Sulfate Dosing Regimens for Women With Preeclampsia: A Population Pharmacokinetic Exposure-Response Modeling and Simulation Study.

J Clin Pharmacol 2019 11 3;59(11):1519-1526. Epub 2019 Jun 3.

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.

Magnesium sulfate is the anticonvulsant of choice for eclampsia prophylaxis and treatment; however, the recommended dosing regimens are costly and cumbersome and can be administered only by skilled health professionals. The objectives of this study were to develop a robust exposure-response model for the relationship between serum magnesium exposure and eclampsia using data from large studies of women with preeclampsia who received magnesium sulfate, and to predict eclampsia probabilities for standard and alternative (shorter treatment duration and/or fewer intramuscular injections) regimens. Exposure-response modeling and simulation were applied to existing data. A total of 10 280 women with preeclampsia who received magnesium sulfate or placebo were evaluated. An existing population pharmacokinetic model was used to estimate individual serum magnesium exposure. Logistic regression was applied to quantify the serum magnesium area under the curve-eclampsia rate relationship. Our exposure-response model-estimated eclampsia rates were comparable to observed rates. Several alternative regimens predicted magnesium peak concentration < 3.5 mmol/L (empiric safety threshold) and eclampsia rate ≤ 0.7% (observed response threshold), including 4 g intravenously plus 10 g intramuscularly followed by either 8 g intramuscularly every 6 hours × 3 doses or 10 g intramuscularly every 8 hours × 2 doses and 10 g intramuscularly every 8 hours × 3 doses. Several alternative magnesium sulfate regimens with comparable model-predicted efficacy and safety were identified that merit evaluation in confirmatory clinical trials.
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http://dx.doi.org/10.1002/jcph.1448DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6790709PMC
November 2019

An outcome-based definition of low birthweight for births in low- and middle-income countries: a secondary analysis of the WHO global survey on maternal and perinatal health.

BMC Pediatr 2019 05 27;19(1):166. Epub 2019 May 27.

Department of Reproductive Health and Research World Health Organization, Avenue Appia 20, CH-1211, Geneva 27, Switzerland.

Background: 2500 g has been used worldwide as the definition of low birthweight (LBW) for almost a century. While previous studies have used statistical approaches to define LBW cutoffs, a LBW definition using an outcome-based approach has not been evaluated. We aimed to identify an outcome-based definition of LBW for live births in low- and middle-income countries (LMICs), using data from a WHO cross-sectional survey on maternal and perinatal health outcomes in 23 countries.

Methods: We performed a secondary analysis of all singleton live births in the WHO Global Survey (WHOGS) on Maternal and Perinatal Health, conducted in African and Latin American countries (2004-2005) and Asian countries (2007-2008). We used a two-level logistic regression model to assess the risk of early neonatal mortality (ENM) associated with subgroups of birthweight (< 1500 g, 1500-2499 g with 100 g intervals; 2500-3499 g as the reference group). The model adjusted for potential confounders, including maternal complications, gestational age at birth, mode of birth, fetal presentation and facility capacity index (FCI) score. We presented adjusted odds ratios (aORs) with 95% confidence intervals (CIs). A lower CI limit of at least two was used to define a clinically important definition of LBW.

Results: We included 205,648 singleton live births at 344 facilities in 23 LMICs. An aOR of at least 2.0 for the ENM outcome was observed at birthweights below 2200 g (aOR 3.8 (95% CI; 2.7, 5.5) of 2100-2199 g) for the total population. For Africa, Asia and Latin America, the 95% CI lower limit aORs of at least 2.0 were observed when birthweight was lower than 2200 g (aOR 3.6 (95% CI; 2.0, 6.5) of 2100-2199 g), 2100 g (aOR 7.4 (95% CI; 5.1, 10.7) of 2000-2099 g) and 2200 g (aOR 6.1 (95% CI; 3.4, 10.9) of 2100-2199 g) respectively.

Conclusion: A birthweight of less than 2200 g may be an outcome-based threshold for LBW in LMICs. Regional-specific thresholds of low birthweight (< 2200 g in Africa, < 2100 g in Asia and < 2200 g in Latin America) may also be warranted.
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http://dx.doi.org/10.1186/s12887-019-1546-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6535858PMC
May 2019

Developing measures for WHO recommendations on antenatal care for a positive pregnancy experience: a conceptual framework and scoping review.

BMJ Open 2019 04 24;9(4):e024130. Epub 2019 Apr 24.

Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Objectives: In response to the newest WHO recommendations on routine antenatal care (ANC) for pregnant women and adolescent girls, this paper identifies the literature on existing ANC measures, presents a conceptual framework for quality ANC, maps existing measures to specific WHO recommendations, identifies gaps where new measures are needed to monitor the implementation and impact of routine ANC and prioritises measures for capture.

Methods: We conducted searches in four databases and five websites. Searches and application of inclusion/exclusion criteria followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow approach for scoping reviews. Data were extracted on measure information, methodology, methodological work and implementation. We adapted and refined a conceptual framework for routine ANC based on these measures.

Results: This scoping review uncovered 58 resources describing 46 existing measures that align with WHO recommendations and good clinical practices for ANC. Of the 42 WHO-recommended ANC interventions and four good clinical practices included in this scoping review, only 14 WHO-recommended interventions and three established good clinical practices could potentially be measured immediately using existing measures. Recommendations addressing the integration of ANC with allied fields are likelier to have existing measures than recommendations that focus on maternal health. When mapped to our conceptual framework, existing measures prioritise content of care and health systems; measures for girls' and women's experiences of care are notably lacking. Available data sources for non-existent measures are currently limited.

Conclusion: Our research updates prior efforts to develop comprehensive measures of quality ANC and raises awareness of the need to better assess experiences of ANC. Given the inadequate number and distribution of existing ANC measures across the quality of care conceptual framework domains, new standardised measures are required to assess quality of routine ANC. Girls' and women's voices deserve greater acknowledgement when measuring the quality and delivery of ANC.
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http://dx.doi.org/10.1136/bmjopen-2018-024130DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6502222PMC
April 2019

Analgesia during Labor and Vaginal Birth among Women with Severe Maternal Morbidity: Secondary Analysis from the WHO Multicountry Survey on Maternal and Newborn Health.

Biomed Res Int 2019 13;2019:7596165. Epub 2019 Feb 13.

Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.

Aim: To evaluate the use of analgesia for vaginal birth, in women with and without severe maternal morbidity (SMM) and to describe sociodemographic, clinical, and obstetric characteristics and maternal and perinatal outcomes associated with labor analgesia.

Methods: Secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health (WHO-MCS), a global cross-sectional study performed between May 2010 and December 2011 in 29 countries. Women who delivered vaginally and had an SMM were included in this analysis and were then divided into two groups: those who received and those who did not receive analgesia for labor/delivery. We further compared maternal characteristics and maternal and perinatal outcomes between these two groups.

Results: From 314,623 women originally included in WHO-MCS, 9,788 developed SMM and delivered vaginally, 601 (6.1%) with analgesia and 9,187 (93.9%) without analgesia. Women with SMM were more likely to receive analgesia than those who did not experience SMM. Global distribution of SMM was similar; however, the use of analgesia was less prevalent in Africa. Higher maternal education, previous cesarean section, and nulliparity were factors associated with analgesia use. Analgesia was not an independent factor associated with an increase of severe maternal outcome (Maternal Near Miss + Maternal Death).

Conclusions: The overall use of analgesia for vaginal delivery is low but women with SMM are more likely to receive analgesia during labor. Social conditions are closely linked with the likelihood of having analgesia during delivery and such a procedure is not associated with increased adverse maternal outcomes. Expanding the availability of analgesia in different levels of care should be a concern worldwide.
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http://dx.doi.org/10.1155/2019/7596165DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6393865PMC
July 2019

Reducing the global burden of disease in childhood - Authors' reply.

Lancet Glob Health 2019 04;7(4):e416

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

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http://dx.doi.org/10.1016/S2214-109X(19)30061-0DOI Listing
April 2019

A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.

N Engl J Med 2019 03;380(11):1012-1021

From the Institutes of Metabolism and Systems Research (D.L., A. Coomarasamy) and Applied Health Research (A. Wilson, C.A.H., L.M., J.R.B.B.) and the Health Economics Unit (T.R., I.G.), University of Birmingham, Birmingham, the Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham (J. Daniels), Population Health Sciences, University of Bristol, Bristol (A. Merriel), the Institute of Translational Medicine, University of Liverpool (A. Weeks), and the Liverpool School of Tropical Medicine and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (S.B.-Z., N.D.), Liverpool, and the Department of Obstetrics and Gynaecology, St. George's University of London, London (S.A.) - all in the United Kingdom; the Department of Obstetrics and Gynaecology, College of Medicine, Blantyre (C. Mhango, R.M., F.T., T.N., A. Chirwa, C. Mphasa, T.T.), and Kamuzu Central Hospital, Lilongwe (G.C., C. Mwalwanda, A. Mboma) - both in Malawi; the Aga Khan University Hospital and Medical College Foundation, Karachi, Pakistan (R.Q., I.A., H.I.); Special Program of Research, Development, and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva (O.T.O., A.M.G.); Ifakara Health Institute, Dar es Salaam, Tanzania (G.M., J.C., G.W., B.S.); Sanyu Africa Research Institute and Mbale Regional Referral Hospital, Mbale (J. Ditai, C.O.T., J.A.), and Soroti Regional Referral Hospital, Soroti (J.E., H.U., M.I., J.J.M.) - all in Uganda; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública and Instituto de Investigación Sanitaria, Madrid (J.Z.); and the Research Centre for Global Child Health, the Hospital for Sick Children, Toronto (Z.A.B.).

Background: Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important complication of this surgery, particularly in low-resource countries.

Methods: We conducted a double-blind, placebo-controlled, randomized trial investigating whether antibiotic prophylaxis before surgery to complete a spontaneous abortion would reduce pelvic infection among women and adolescents in low-resource countries. We randomly assigned patients to a single preoperative dose of 400 mg of oral doxycycline and 400 mg of oral metronidazole or identical placebos. The primary outcome was pelvic infection within 14 days after surgery. Pelvic infection was defined by the presence of two or more of four clinical features (purulent vaginal discharge, pyrexia, uterine tenderness, and leukocytosis) or by the presence of one of these features and the clinically identified need to administer antibiotics. The definition of pelvic infection was changed before the unblinding of the data; the original strict definition was two or more of the clinical features, without reference to the administration of antibiotics.

Results: We enrolled 3412 patients in Malawi, Pakistan, Tanzania, and Uganda. A total of 1705 patients were assigned to receive antibiotics and 1707 to receive placebo. The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval [CI], 0.56 to 1.04; P = 0.09). Pelvic infection according to original strict criteria was diagnosed in 1.5% (26 of 1700 pregnancies) and 2.6% (44 of 1704 pregnancies), respectively (risk ratio, 0.60; 95% CI, 0.37 to 0.96). There were no significant between-group differences in adverse events.

Conclusions: Antibiotic prophylaxis before miscarriage surgery did not result in a significantly lower risk of pelvic infection, as defined by pragmatic broad criteria, than placebo. (Funded by the Medical Research Council and others; AIMS Current Controlled Trials number, ISRCTN97143849.).
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http://dx.doi.org/10.1056/NEJMoa1808817DOI Listing
March 2019