Publications by authors named "Annie Regi"

19 Publications

  • Page 1 of 1

Breast milk contains red cell isohaemagglutinins: An observational study of 176 mothers.

Vox Sang 2022 Jun 26;117(6):847-852. Epub 2022 Jan 26.

Department of Transfusion Medicine and Immunohaematology, Christian Medical College, Vellore, India.

Background And Objectives: Maternal antibodies are transferred to the child, predominantly IgG, via the transplacental route, and mostly IgA through breast milk. Cases reported by us and others have shown the transfer of red cell allo-antibodies through breast milk. This study was conducted to assess the presence of isohaemagglutinins in breast milk, the range of titres, and the correlation between breast milk and maternal plasma titres.

Materials And Methods: A total of 176 mothers were recruited in this study. Breast milk was collected after sufficient feeding was established and within 2-5 days of delivery in a sterile container without any anticoagulant. Antibody screen, identification and titres were performed on maternal plasma as well as breast milk.

Results: Anti-A and anti-B in breast milk corresponding to their respective maternal blood groups were found in all the samples. This study has shown titres in the breast milk of anti-A and anti-B ranging from 2 to 1024 in both saline and Coombs phases. There was no association between plasma and breast milk titres, thus making it impossible to predict which mother may potentially transfer a larger amount of these haemagglutinins. Isotypes of anti-A and anti-B were evaluated in both plasma and breast milk of 11 samples, which showed predominantly IgG in 7 (63.63%) and predominantly IgA in 4 (36.36%) samples.

Conclusion: Our study demonstrates the presence of a wide range of titres for IgG antibodies of the ABO blood group system in breast milk. The clinical impact of this finding needs to be studied further, as it assumes great relevance in developing countries where anaemia continues to challenge young infants.
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http://dx.doi.org/10.1111/vox.13253DOI Listing
June 2022

Risk Factors for Endometrial Carcinoma in Women with Postmenopausal Bleeding.

J Obstet Gynaecol India 2021 Aug 14;71(4):417-423. Epub 2021 Mar 14.

Department of Gynaecologic Oncology, Christian Medical College, Vellore, 632004 India.

Objectives: Most patients with postmenopausal bleeding do not have endometrial cancer. The primary objective was to evaluate risk factors for endometrial cancer among postmenopausal women with bleeding.

Methods: This was a retrospective cross-sectional study. Women with postmenopausal bleeding presenting to a gynecology clinic were included in the study. Data on potential risk factors for endometrial cancer or atypical hyperplasia were collected. Univariate and multivariate analyses were performed to assess the risk factors.

Results: Among 212 women studied, 24 (11.3%) women had endometrial cancer. There were 38 (17.9%) with cervical cancer and 3 (1.4%) with ovarian cancer. Women 55 or older had an odds ratio of 7.5 (95% CI 2.2 to 26.2) as compared to women below 55 years ( value = 0.002). Women with 2 or more episodes of postmenopausal bleeding had an odds ratio of 4.9 (95% CI 1.1 to 23.0) and those who had either diabetes or hypertension had an odds ratio of 3.1 (95% CI 1.3 to 7.4) of endometrial cancer as compared to those who did not.

Conclusions: A third of patients with postmenopausal bleeding had a gynecological cancer. Age, frequency of bleeding, diabetes and hypertension, and increased endometrial thickness were independent risk factors for endometrial cancer.
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http://dx.doi.org/10.1007/s13224-021-01464-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8418577PMC
August 2021

Maternal and Perinatal Outcomes of Influenza in Pregnancy after Treatment with Oseltamivir.

J Glob Infect Dis 2021 Jan-Mar;13(1):20-26. Epub 2021 Jan 29.

Global Health Center, Cincinnati Children's Hospital, Cincinnati, OH, USA.

Context: Influenza infection in pregnancy causes 4%-8% case fatality and five times more perinatal mortality. Influenza is a major contributor to mortality in developing countries; however, the morbidity has largely been underestimated. Public health interventions for prevention are also lacking.

Aims: This study aimed to determine the seasonality of influenza in pregnant Indian women and to estimate the maternal and perinatal morbidity after treatment with oseltamivir.

Settings And Design: This was a prospective observational cohort study, conducted in a tertiary hospital.

Subjects And Methods: Pregnant women with ILI (influenza-like illness) were recruited into Cohort 1 (polymerase chain reaction [PCR] positive) and Cohort 2 (PCR negative). Gestational age-matched asymptomatic controls formed Cohort 3. Women in Cohort 1 received oseltamivir for 5 days. The incidence of small-for-gestational age (SGA) and preterm birth were the primary outcomes. Maternal and neonatal morbidity formed the secondary outcomes.

Statistical Analysis: Unmatched (Cohort 1 and 2) and matched analysis (Cohort 1 and 3) were done. Student's -test and Chi-square test were used to compare between variables.

Results: Year-round incidence of influenza was recorded. Severe illness was more in Cohort 1 compared to Cohort 2 (36.2% vs. 6.3%; < 0.001). SGA was comparable in all the cohorts (13%). Preterm birth (7.8% vs. 3.3%; < 0.08; relative risk-2.75) was considerably high in Cohort 1. Secondary maternal and neonatal outcomes were similar between the groups.

Conclusion: Influenza in pregnancy showed year-round incidence and increased maternal and neonatal morbidity despite treatment with oseltamivir. We suggest the need for newer interventions to curtail the illness in pregnancy.
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http://dx.doi.org/10.4103/jgid.jgid_157_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8054794PMC
January 2021

Peripartum cardiomyopathy: An analysis of clinical profiles and outcomes from a tertiary care centre in southern India.

Obstet Med 2020 Dec 17;13(4):179-184. Epub 2019 Jun 17.

Department of General Medicine, Unit - III (Obstetric Medicine), Christian Medical College, Vellore, India.

Peripartum cardiomyopathy is a syndrome of maternal heart failure with decreased left ventricular ejection fraction affecting maternal and fetal well-being. We analysed clinical profiles and outcomes in women with peripartum cardiomyopathy enrolled retrospectively from a tertiary care centre in southern India (1 January 2008-31 December 2014). The incidence of peripartum cardiomyopathy was one case per 1541 live births. Fifty-four women with a mean age of 25.5 years and mean gestational age of 35.4 weeks were recruited; 35 were primigravidae. Maternal and fetal deaths occurred in 9.3% and 24.1% of subjects, respectively. Mild-to-moderate maternal anaemia (80-110 g/L) was associated with fetal mortality (p = 0.02). Reduced left ventricular ejection fraction (<30%, p = 0.04) and cardiogenic shock (p = 0.01) were significantly associated with adverse maternal outcomes. Forty per cent of women were followed up after 24.2 ± 17.7 months, and in these women a significant increase in left ventricular ejection fraction was seen (mean 16.4%, p < 0.01); all were asymptomatic. Peripartum cardiomyopathy with poor left ventricular ejection fraction and shock is associated with adverse maternal outcomes, while non-severe maternal anaemia predisposes to adverse fetal outcomes. Significant left ventricular ejection fraction recovery occurred on follow-up.
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http://dx.doi.org/10.1177/1753495X19851397DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726167PMC
December 2020

Enzyme-linked immunosorbent assay (ELISA) versus Venereal Disease Research Laboratory test (VDRL) and rapid plasma reagin test (RPR) for screening of syphilis in pregnant women.

Int J Gynaecol Obstet 2020 Jul 23;150(1):103-107. Epub 2020 Apr 23.

Department of Clinical Microbiology, Christian Medical College, Vellore, Tamil Nadu, India.

Objective: To evaluate a treponemal enzyme-linked immunosorbent assay (ELISA) as an alternative screening test for syphilis in pregnant women.

Methods: A cross-sectional study of diagnostic test accuracy was carried out in a large volume laboratory from a tertiary care center. A total of 416 serum samples, including 102 archived syphilis Treponema pallidum hemagglutination (TPHA)-positive samples and 314 samples from pregnant women, were used to determine the sensitivity and specificity of ELISA. All the samples were subjected to Venereal Disease Research Laboratory (VDRL), rapid plasma reagin (RPR), ELISA, and TPHA tests. Performance characteristics of VDRL, RPR, and ELISA were calculated with TPHA as a reference standard test.

Results: VDRL and RPR exhibited higher false positivity of 10.5% and 9.6%, respectively, compared to 2.5% by ELISA. The sensitivity and specificity of ELISA were 98% and 97.5%, of VDRL were 71.6% and 89.5%, and of RPR were 73.5% and 90.5%, respectively. Moreover, ELISA had an excellent agreement (kappa=0.9) with TPHA compared to VDRL/RPR which had a moderate agreement (kappa=0.6) only.

Conclusion: ELISA has the potential to replace VDRL/RPR as a screening test for syphilis in centers that can perform ELISA, especially for antenatal screening.
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http://dx.doi.org/10.1002/ijgo.13154DOI Listing
July 2020

Angiogenic factors and uterine artery Doppler in predicting preeclampsia and associated adverse outcomes in a tertiary hospital in south India.

Pregnancy Hypertens 2019 04 8;16:26-30. Epub 2019 Feb 8.

Department of Obstetrics and Gynecology, Christian Medical College and Hospital, Vellore, Tamil Nadu, India.

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http://dx.doi.org/10.1016/j.preghy.2019.01.012DOI Listing
April 2019

How safe is metformin when initiated in early pregnancy? A retrospective 5-year study of pregnant women with gestational diabetes mellitus from India.

Diabetes Res Clin Pract 2018 Mar 8;137:47-55. Epub 2018 Jan 8.

Department of Endocrinology, Diabetes and Metabolism, Christian Medical College (CMC) Vellore, India.

Background: The initiation of metformin in early pregnancy in Gestational Diabetes mellitus (GDM) remains controversial. The aim of our study was to assess the influence of Metformin on maternal and fetal outcomes when initiated within the first trimester of pregnancy in GDM.

Methods And Materials: A retrospective analysis of 540 women with diabetes complicating pregnancy (IADPSG criteria) over five years (January 2011 to May 2016) was done. The study population comprised of patients initiated on (a) metformin within the first trimester (Group A:n = 186), (b) metformin after the first trimester (Group B:n = 203) and (c) insulin at any time during their pregnancy (Group C:n = 151). The primary outcomes compared were prematurity, respiratory distress, birth trauma, 5-min APGAR score, neonatal hypoglycaemia and need for phototherapy, while secondary outcomes compared were neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance.

Results: Individual and composite primary or secondary outcomes in group A were similar to Groups B and C, though numerically higher premature births were seen in Group A. There was a 1.3% overall incidence of stillbirths/IUD, while 1.11% congenital anomalies were noted of which 2.15% were in group A and 1.32% were in Group C (p = .16).

Conclusions: The initiation of metformin within the first trimester of pregnancy has no significant adverse maternal or fetal outcomes. However, vigilance for premature births is recommended in women exposed to metformin in early pregnancy.
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http://dx.doi.org/10.1016/j.diabres.2018.01.002DOI Listing
March 2018

Comprehensive Maturity Onset Diabetes of the Young (MODY) Gene Screening in Pregnant Women with Diabetes in India.

PLoS One 2017 17;12(1):e0168656. Epub 2017 Jan 17.

Department of Endocrinology, Diabetes & Metabolism, Christian Medical College, Vellore, India.

Pregnant women with diabetes may have underlying beta cell dysfunction due to mutations/rare variants in genes associated with Maturity Onset Diabetes of the Young (MODY). MODY gene screening would reveal those women genetically predisposed and previously unrecognized with a monogenic form of diabetes for further clinical management, family screening and genetic counselling. However, there are minimal data available on MODY gene variants in pregnant women with diabetes from India. In this study, utilizing the Next generation sequencing (NGS) based protocol fifty subjects were screened for variants in a panel of thirteen MODY genes. Of these subjects 18% (9/50) were positive for definite or likely pathogenic or uncertain MODY variants. The majority of these variants was identified in subjects with autosomal dominant family history, of whom five were in women with pre-GDM and four with overt-GDM. The identified variants included one patient with HNF1A Ser3Cys, two PDX1 Glu224Lys, His94Gln, two NEUROD1 Glu59Gln, Phe318Ser, one INS Gly44Arg, one GCK, one ABCC8 Arg620Cys and one BLK Val418Met variants. In addition, three of the seven offspring screened were positive for the identified variant. These identified variants were further confirmed by Sanger sequencing. In conclusion, these findings in pregnant women with diabetes, imply that a proportion of GDM patients with autosomal dominant family history may have MODY. Further NGS based comprehensive studies with larger samples are required to confirm these finding.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0168656PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5240948PMC
August 2017

Masked hypoglycemia in pregnancy.

J Diabetes 2017 Aug 14;9(8):778-786. Epub 2016 Nov 14.

Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, India.

Background: Hypoglycemia is a major hindrance for optimal glycemic control in women with gestational diabetes mellitus (GDM) on insulin. In the present study, masked hypoglycemia (glucose <2.77mmol/L for ≥30 min) was estimated in pregnant women using a continuous glucose monitoring (CGM) system.

Methods: Twenty pregnant women with GDM on insulin (cases) and 10 age-matched euglycemic pregnant women (controls) between 24 and 36 weeks gestation were recruited. Both groups performed self-monitoring of blood glucose (SMBG) and underwent CGM for 72 h to assess masked hypoglycemia. Masked hypoglycemic episodes were further stratified into two groups based on interstitial glucose (2.28-2.77 and ≤2.22 mmol/L).

Results: Masked hypoglycemia was recorded in 35% (7/20) of cases and 40% (4/10) of controls using CGM, with an average of 1.28 and 1.25 episodes per subject, respectively. Time spent at glucose levels between 2.28 and 2.77 mmol/L did not differ between the two groups (mean 114 vs 90 min; P = 0.617), but cases spent a longer time with glucose ≤2.2 mmol/L. Babies born to women with GDM were significantly lighter than those born to controls (2860 vs 3290 g; P = 0.012). There was no significant difference in birth weight within the groups among babies born to women with or without hypoglycemia.

Conclusion: Euglycemic pregnant women and those with GDM on insulin had masked hypoglycemia. Masked hypoglycemia was not associated with adverse maternal or fetal outcomes. Therefore, low glucose levels in the hypoglycemic range may represent a physiologic adaptation in pregnancy. This response is exaggerated in women with GDM on insulin.
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http://dx.doi.org/10.1111/1753-0407.12485DOI Listing
August 2017

Birth weight centiles by gestational age for twins born in south India.

BMC Pregnancy Childbirth 2016 Mar 24;16:64. Epub 2016 Mar 24.

Making Pregnancy Safer Department, World Health Organization, Geneva, Switzerland.

Background: Birth weight centile curves are commonly used as a screening tool and to assess the position of a newborn on a given reference distribution. Birth weight of twins are known to be less than those of comparable singletons and twin-specific birth weight centile curves are recommended for use. In this study, we aim to construct gestational age specific birth weight centile curves for twins born in south India.

Methods: The study was conducted at the Christian Medical College, Vellore, south India. The birth records of all consecutive pregnancies resulting in twin births between 1991 and 2005 were reviewed. Only live twin births between 24 and 42 weeks of gestation were included. Birth weight centiles for gestational age were obtained using the methodology of generalized additive models for location, scale and shape (GAMLSS). Centiles curves were obtained separately for monochorionic and dichorionic twins.

Results: Of 1530 twin pregnancies delivered during the study period (1991-2005), 1304 were included in the analysis. The median gestational age at birth was 36 weeks (1st quartile 34, 3rd quartile 38 weeks). Smoothed percentile curves for birth weight by gestational age increased progressively till 38 weeks and levels off thereafter. Compared with dichorionic twins, monochorionic twins had lower birth weight for gestational age from after 27 weeks.

Conclusions: We provide centile values of birth weight at 24 to 42 completed weeks of gestation for twins born in south India. These charts could be used both in routine clinical assessments and epidemiological studies.
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http://dx.doi.org/10.1186/s12884-016-0850-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4806424PMC
March 2016

Risk Factors for Stress During Antenatal Period Among Pregnant Women in Tertiary Care Hospital of Southern India.

J Clin Diagn Res 2015 Oct 1;9(10):QC01-5. Epub 2015 Oct 1.

Assistant Professor, Department of Biostatistics, Christian Medical College Hospital , Vellore, Tamilnadu, India .

Background: The well-being of an infant may be affected when the mother is subjected to psychosocial stress during her pregnancy. Mothers exposed to stressful conditions were more prone for preterm birth than those without any stress. In this study perceived stress has been used as an indicator of levels of stress. There are very few studies published from developing countries on the levels of perceived stress and its causes in pregnant women.

Materials And Methods: This study employed a cross-sectional assessment of pregnant women attending the outpatient services of a tertiary care hospital for regular antenatal check-up. Women not known to have any risk factors at 28 weeks to 34 weeks of pregnancy who agreed to participate in the study were interviewed to assess the perceived stress score.

Results: Among the total patients 57.7% were primigravida and the mean score on perceived stress scale was 13.5±5.02. The majority of the group (102; 65.4%) scored higher than the mean value of total score on the perceived stress scale. Unplanned pregnancy and husband's employment status were associated with high levels of perceived stress in multivariate analysis in this set of women.

Conclusion: Individual as well as pregnancy related factors can contribute to perceived stress in pregnant women. With the established relationship between maternal mental health, pregnancy outcome and infant growth, the assessment and management of stress early in the pregnancy is crucial.
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http://dx.doi.org/10.7860/JCDR/2015/13973.6580DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4625287PMC
October 2015

Aplastic anemia in pregnancy.

J Obstet Gynaecol India 2014 Dec 14;64(Suppl 1):26-8. Epub 2013 Aug 14.

Department of Obstetrics and Gynecology Unit III, Christian Medical College, Vellore, 632004 India.

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http://dx.doi.org/10.1007/s13224-013-0431-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4228002PMC
December 2014

Absence of G1528C mutation in long-chain 3-hydroxyacyl-CoA dehydrogenase in four Indian patients with pregnancy-related liver disease.

Indian J Gastroenterol 2014 Jul;33(4):387-9

The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, 632 004, India.

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http://dx.doi.org/10.1007/s12664-013-0408-0DOI Listing
July 2014

Preliminary experience with use of recombinant activated factor VII to control postpartum hemorrhage in acute fatty liver of pregnancy and other pregnancy-related liver disorders.

Indian J Gastroenterol 2013 Jul 10;32(4):268-71. Epub 2013 Mar 10.

Department of Hepatology, Christian Medical College, Vellore 632 004, India.

Control of postpartum hemorrhage is difficult in patients with coagulopathy due to acute liver failure. Recombinant activated factor VII (rFVIIa) can help in control of bleed; however, it has short duration of action (2-4 h). The study aimed to report the use of rFVIIa in this setting. We retrospectively analyzed all patients with acute liver failure secondary to pregnancy-related liver disorders who received rFVIIa for control of postpartum hemorrhage (six patients, all six met diagnostic criteria for acute fatty liver of pregnancy). One dose of rFVIIa achieved adequate control of bleeding in five patients, while one patient needed a second dose. rFVIIa administration corrected coagulopathy and significantly reduced requirement of packed red cells and other blood products. No patient had thrombotic complications. In conclusion, rFVIIa was a useful adjunct to standard management in postpartum hemorrhage secondary to acute liver failure of pregnancy-related liver disorders.
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http://dx.doi.org/10.1007/s12664-013-0315-4DOI Listing
July 2013

New birth weight reference standards customised to birth order and sex of babies from South India.

BMC Pregnancy Childbirth 2013 Feb 14;13:38. Epub 2013 Feb 14.

Department of Biostatistics, Christian Medical College and Hospital, Vellore 632004, India.

Background: The foetal growth standards for Indian children which are available today suffer due to methodological problems. These are, for example, not adhering to the WHO recommendation to base gestational age on the number of completed weeks and secondly, not excluding mothers with risk factors. This study has addressed both the above issues and in addition provides birthweight reference ranges with regard to sex of the baby and maternal parity.

Methods: Data from the labour room register from 1996 to 2010 was obtained. A rotational sampling scheme was used i.e. the 12 months of the year were divided into 4 quadrants. All deliveries in January were considered to represent the first quadrant. Similarly all deliveries in April, July and October were considered to represent 2nd, 3rd and 4th quadrants. In each successive year different months were included in each quadrant. Only those mothers aged 20-39 years and delivered between 24 to 42 weeks gestational age were considered. Those mothers with obstetric risk factors were excluded. The reference standards were fitted using the Generalized Additive Models for Location Scale and Shape (GAMLSS) method for Box-Cox t distribution with cubic spline smoothing.

Results: There were 41,055 deliveries considered. When women with risk factors were excluded 19,501 deliveries could be included in the final analysis. The male babies of term firstborn were found to be 45 g heavier than female babies. The mean birthweights were 2934 g and 2889.5 g respectively. Similarly, among the preterm babies, the first born male babies weighed 152 g more than the female babies. The mean birthweights were 1996 g and 1844 g respectively.In the case of later born babies, the term male babies weighed 116 grams more than the females. The mean birth weights were 3085 grams and 2969 grams respectively. When considering later born preterm babies, the males outweighed the female babies by 111 grams. The mean birthweights were 2089 grams and 1978 grams respectively. There was a substantial agreement range from k=.883, (p<.01) to k=.943, (p<.01) between adjusted and unadjusted percentile classification for the subgroups of male and female babies and first born and later born ones.Birth weight charts were adjusted for maternal height using regression methods. The birth weight charts for the first born and later born babies were regrouped into 4 categories, including male and female sexes of the babies. Reference ranges were acquired both for term and preterm babies.With economic reforms, one expects improvement in birthweights. The mean (sd) birthweights of the year 1996 was 2846 (562) as compared to year 2010 (15 years later) which was 2907 (571). There was only a difference of 61 grams in the mean birthweights over one and a half decade.

Conclusion: New standards are presented from a large number of deliveries over 15 years, customised to the maternal height, from a south Indian tertiary hospital. Reference ranges are made available separately for first born or later born babies, for male and female sexes and for term and preterm babies.
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http://dx.doi.org/10.1186/1471-2393-13-38DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3583685PMC
February 2013

Low prevalence of Chlamydia trachomatis infection in non-urban pregnant women in Vellore, S. India.

PLoS One 2012 2;7(5):e34794. Epub 2012 May 2.

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States of America.

Objective: To determine the prevalence and risk factors for Chlamydia trachomatis (CT) infection in pregnant women and the rate of transmission of CT to infants.

Methods: Pregnant women (≥28 weeks gestation) in Vellore, South India were approached for enrollment from April 2009 to January 2010. After informed consent was obtained, women completed a socio-demographic, prenatal, and sexual history questionnaire. Endocervical samples collected at delivery were examined for CT by a rapid enzyme test and nucleic acid amplification test (NAAT). Neonatal nasopharyngeal and conjunctival swabs were collected for NAAT testing.

Results: Overall, 1198 women were enrolled and 799 (67%) endocervical samples were collected at birth. Analyses were completed on 784 participants with available rapid and NAAT results. The mean age of women was 25.8 years (range 18-39 yrs) and 22% (95% CI: 19.7-24.4%) were primigravida. All women enrolled were married; one reported >one sexual partner; and six reported prior STI. We found 71 positive rapid CT tests and 1/784 (0.1%; 95% CI: 0-0.38%) true positive CT infection using NAAT.

Conclusions: To our knowledge, this is the largest study on CT prevalence amongst healthy pregnant mothers in southern India, and it documents a very low prevalence with NAAT. Many false positive results were noted using the rapid test. These data suggest that universal CT screening is not indicated in this population.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0034794PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3342301PMC
September 2012

Treatment approaches for preeclampsia in low-resource settings: A randomized trial of the Springfusor pump for delivery of magnesium sulfate.

Pregnancy Hypertens 2012 Jan 11;2(1):32-8. Epub 2011 Oct 11.

Gynuity Health Projects, New York, NY, USA.

Objective: To test the safety, efficacy, and acceptability of a simple, mechanically flow-controlled pump (Springfusor®) for the delivery of magnesium sulfate for the treatment of preeclampsia.

Design: Eligible women (n=300) had blood pressure ⩾140/100mmHg, and proteinuria ⩾1+ (30mgdL); the clinic team determined that they were likely to benefit from magnesium sulfate. Women were randomized to 24h of magnesium sulfate by either IV administered by the Springfusor® pump (n=147) or standard hospital practice - IV loading dose administered manually followed by maintenance therapy using an IM route of administration (n=153).

Main Outcome Measures: Our primary outcome of interest was the safety and efficacy of the Springfusor pump including the side and adverse effects experienced during drug administration. Data on side effects, patient acceptability, delivery complications, and maternal and neonatal outcomes were collected.

Results: Fewer women stopped treatment due to side effects, toxicity, oliguria or renal failure, or women's request in the Springfusor arm (4% or 6 of 147 women) compared to the Standard of Care arm (6.5% or 10 of 153 women). Women in the Springfusor arm reported significantly less nausea, headache, and pain than women in the Standard of Care arm. Almost all women (97%) in the Springfusor arm reported their pain level as 'acceptable' or 'very acceptable' compared to only 30% of women given the Standard of Care.

Conclusion: The Springfusor pump may offer an alternative to intramuscular administration of magnesium sulfate where electronic pumps are not available.
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http://dx.doi.org/10.1016/j.preghy.2011.09.002DOI Listing
January 2012

Amnioinfusion for relief of recurrent severe and moderate variable decelerations in labor.

J Reprod Med 2009 May;54(5):295-302

Department of Obstetrics and Gynecology, Christian Medical College Hospital, Vellore, India.

Objective: To determine whether intrapartum amnioinfusion (AI) relieves recurrent moderate and severe variable decelerations in laboring women with clear or grade I meconium-stained amniotic fluid and reduces cesarean section rate for fetal distress.

Study Design: A randomized controlled trial was conducted in labor unit of Christian Medical College Hospital, Vellore, India, between October 2003 and September 2004. Women were randomized to receive AI (group I) and not to receive it (group II).

Results: A total of 150 women (75 in each group) were included in the study. There was significant relief of variable decelerations in group I and no difference in overall cesarean section rate but significant reduction in cesarean section rate for fetal distress in group I, and significant reduction in cesarean section rate for fetal distress in nulliparous women of group I. Neonatal acidemia was also significantly reduced in the nulliparous women receiving AI. The duration of maternal postpartum hospital stay was significantly reduced in group I. There were no adverse maternal or neonatal outcomes.

Conclusion: AI was a beneficial therapeutic intervention in women patients showing fetal distress in first stage of labor, and it reduced cesarean section for fetal distress and neonatal acidemia.
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May 2009
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