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Sheldon W.R.,Gynuity Health Projects
BJOG : an international journal of obstetrics and gynaecology | Year: 2014

To explore the clinical practices, risks, and maternal outcomes associated with postpartum haemorrhage (PPH). Secondary analysis of cross-sectional data. A total of 352 health facilities in 28 countries. A total of 274 985 women giving birth between 1 May 2010 and 31 December 2011. We used multivariate logistic regression to examine factors associated with PPH among all births, and the Pearson chi-square test to examine correlates of severe maternal outcomes (SMOs) among women with PPH. All analyses adjust for facility- and country-level clustering. PPH, SMOs, and clinical practices for the management of PPH. Of all the women included in the analysis, 95.3% received uterotonic prophylaxis and the reported rate of PPH was 1.2%. Factors significantly associated with PPH diagnosis included age, parity, gestational age, induction of labour, caesarean section, and geographic region. Among those with PPH, 92.7% received uterotonics for treatment, and 17.2% had an SMO. There were significant differences in the incidence of SMOs by age, parity, gestational age, anaemia, education, receipt of uterotonics for prophylaxis or treatment, referral from another facility, and Human Development Index (HDI) group. The rates of death were highest in countries with low or medium HDIs. Among women with PPH, disparities in the incidence of severe maternal outcomes persist, even among facilities that report capacity to provide all essential emergency obstetric interventions. This highlights the need for better information about the role of institutional capacity, including quality of care, in PPH-related morbidity and mortality. © 2014 RCOG The World Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication. Source

Bracken H.,Gynuity Health Projects
Obstetrics and Gynecology | Year: 2010

OBJECTIVE: To evaluate the ability of women and their providers to assess abortion outcome without the routine use of ultrasonography. METHODS: This multicenter trial enrolled 4,484 women seeking medical abortion at 10 clinics in the United States. Women received the standard medical abortion care with mifepristone-misoprostol in those clinics and blinded clinical assessments before follow-up ultrasonography. Data were collected prospectively on abortion outcomes, receipt of additional treatment, and clinical, laboratory, and ultrasound assessments associated with the procedure. We constructed five model algorithms for evaluating women's postabortion status, each using a different assortment of data. Four of the algorithms (algorithms 1-4) rely on data collected by the woman and on the results of the low-sensitivity pregnancy test. Algorithm 5 relies on the woman's assessment, the results of the pregnancy test, and follow-up physician assessment (sometimes including bimanual or speculum examination). Results: A total of 3,054 women received medical abortion and had adequate data for evaluation. Twenty women (0.7%) had an ongoing pregnancy; 26 (0.9%) received curettage for retained tissue, empiric treatment for possible infection, or both; and 55 (1.8%) received additional uterotonics or other medical abortion-related care. Screening algorithms including patient-observed outcomes, a low-sensitivity pregnancy test, and nonsonographic clinical evaluation were as effective as sonography in identifying women who received interventions at or after the follow-up visit. Conclusion: Relying on women's observations, a low-sensitivity pregnancy test, and clinical examination, women and their providers can accurately assess whether follow-up care is required after medical abortion without routine ultrasonography. Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00120224. © 2010 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins. Source

Chong E.,Gynuity Health Projects
Obstetrics and Gynecology | Year: 2016

OBJECTIVE: To characterize the presence of Clostridium sordellii and Clostridium perfringens in the vagina and rectum, identify correlates of presence, and describe strain diversity and presence of key toxins. METHODS: We conducted an observational cohort study in which we screened a diverse cohort of reproductive-aged women in the United States up to three times using vaginal and rectal swabs analyzed by molecular and culture methods. We used multivariate regression models to explore predictors of presence. Strains were characterized by pulsed-field gel electrophoresis and tested for known virulence factors by polymerase chain reaction assays. RESULTS: Of 4,152 participants enrolled between 2010 and 2013, 3.4% (95% confidence interval [CI] 2.9-4.0) were positive for C sordellii and 10.4% (95% CI 9.5-11.3) were positive for C perfringens at baseline. Among the 66% with follow-up data, 94.7% (95% CI 88.0-98.3) of those positive for C sordellii and 74.4% (95% CI 69.0-79.3) of those positive for C perfringens at baseline were negative at follow-up. At baseline, recent gynecologic surgery was associated with C sordellii presence, whereas a high body mass index was associated with C perfringens presence in adjusted models. Two of 238 C sordellii isolates contained the lethal toxin gene, and none contained the hemorrhagic toxin gene. Substantial strain diversity was observed in both species with few clusters and no dominant clones identified. CONCLUSION: The relatively rare and transient nature of C sordellii and C perfringens presence in the vagina and rectum makes it inadvisable to use any screening or prophylactic approach to try to prevent clostridial infection. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01283828. © 2016 by The American College of Obstetricians and Gynecologists. Source

Bracken H.,Gynuity Health Projects
International Journal of Gynecology and Obstetrics | Year: 2010

Objective: To assess the efficacy and acceptability of home administration of misoprostol for early medical abortion in Indian family planning clinics. Methods: In this prospective cohort study, consenting pregnant women (n = 599) with amenorrhea of 8 weeks or less seeking termination of pregnancy received 200 mg of oral mifepristone followed 48 hours later with 400 μg of oral misoprostol, administered either at home or at the clinic. Results: Almost all women (88.4%) chose to take misoprostol home. There was no statistical difference in success rates between home and clinic users (89.0% vs 92.4%, Pearson χ2 = 0.7; P = 0.395). Most women in both the home (90.7%) and clinic (92.3%) groups were satisfied or very satisfied with the procedure. Conclusion: Home administration of misoprostol is safe and feasible for introduction into medical abortion services in India. © 2009 International Federation of Gynecology and Obstetrics. Source

Starrs A.,Family Care International | Winikoff B.,Gynuity Health Projects
International Journal of Gynecology and Obstetrics | Year: 2012

Clinical and operational evidence indicates that misoprostol is a safe and effective technology for addressing postpartum hemorrhage, a major cause of maternal death. This research has not yet been translated into effective policies, programs, and practice in many parts of the world. Efforts to expand evidence-based use of misoprostol are often complicated by misoprostol's range of indications, insufficient availability, a lack of evidence-based guidelines and provider training, and misconceptions about the drug. The medical and health policy communities need to work together to translate research findings into changes in policy, knowledge, and clinical practice so that we can deliver on the world's promise to improve maternal health. © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. Source

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