A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt

Abstract Background Previous community-based research shows that secondary prevention of postpartum hemorrhage (PPH) with misoprostol only given to women with above-average measured blood loss produces similar clinical outcomes compared to routine administration of misoprostol for prevention of PPH....

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Main Authors: Holly A. Anger, Rasha Dabash, Nevine Hassanein, Emad Darwish, Mohamed Cherine Ramadan, Medhat Nawar, Dyanna Charles, Miral Breebaart, Beverly Winikoff
Format: Article
Language:English
Published: BMC 2020-05-01
Series:BMC Pregnancy and Childbirth
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12884-020-03008-5
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spelling doaj-3c82fe6a500d4fbab04dc647a4f8ffca2020-11-25T03:33:17ZengBMCBMC Pregnancy and Childbirth1471-23932020-05-0120111010.1186/s12884-020-03008-5A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in EgyptHolly A. Anger0Rasha Dabash1Nevine Hassanein2Emad Darwish3Mohamed Cherine Ramadan4Medhat Nawar5Dyanna Charles6Miral Breebaart7Beverly Winikoff8Gynuity Health ProjectsGynuity Health ProjectsIndependent Reproductive Health ConsultantFaculty of Medicine, Alexandria UniversityDepartment of Obstetrics and Gynecology, El Galaa Teaching HospitalEl Beheira Governorate, Ministry of Health and PopulationGynuity Health ProjectsIndependent Public Health ConsultantGynuity Health ProjectsAbstract Background Previous community-based research shows that secondary prevention of postpartum hemorrhage (PPH) with misoprostol only given to women with above-average measured blood loss produces similar clinical outcomes compared to routine administration of misoprostol for prevention of PPH. Given the difficulty of routinely measuring blood loss for all deliveries, more operational models of secondary prevention are needed. Methods This cluster-randomized, non-inferiority trial included women giving birth with nurse-midwives at home or in Primary Health Units (PHUs) in rural Egypt. Two PPH management approaches were compared: 1) 600mcg oral misoprostol given to all women after delivery (i.e. primary prevention, current standard of care); 2) 800mcg sublingual misoprostol given only to women with 350-500 ml postpartum blood loss estimated using an underpad (i.e. secondary prevention). The primary outcome was mean change in pre- and post-delivery hemoglobin. Secondary outcomes included hemoglobin ≥2 g/dL and other PPH interventions. Results Misoprostol was administered after delivery to 100% (1555/1555) and 10.7% (117/1099) of women in primary and secondary prevention clusters, respectively. The mean drop in pre- to post-delivery hemoglobin was 0.37 (SD: 0.91) and 0.45 (SD: 0.76) among women in primary and secondary prevention clusters, respectively (difference adjusted for clustering = 0.01, one-sided 95% CI: < 0.27, p = 0.535). There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions. Conclusions Misoprostol for secondary prevention of PPH is comparable to universal prophylaxis and can be implemented using local materials, such as underpads. Trial registration Clinicaltrials.gov NCT02226588 , date of registration 27 August 2014.http://link.springer.com/article/10.1186/s12884-020-03008-5MisoprostolPostpartum hemorrhageLow and middle income countriesSecondary preventionProphylaxisHome-births
collection DOAJ
language English
format Article
sources DOAJ
author Holly A. Anger
Rasha Dabash
Nevine Hassanein
Emad Darwish
Mohamed Cherine Ramadan
Medhat Nawar
Dyanna Charles
Miral Breebaart
Beverly Winikoff
spellingShingle Holly A. Anger
Rasha Dabash
Nevine Hassanein
Emad Darwish
Mohamed Cherine Ramadan
Medhat Nawar
Dyanna Charles
Miral Breebaart
Beverly Winikoff
A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt
BMC Pregnancy and Childbirth
Misoprostol
Postpartum hemorrhage
Low and middle income countries
Secondary prevention
Prophylaxis
Home-births
author_facet Holly A. Anger
Rasha Dabash
Nevine Hassanein
Emad Darwish
Mohamed Cherine Ramadan
Medhat Nawar
Dyanna Charles
Miral Breebaart
Beverly Winikoff
author_sort Holly A. Anger
title A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt
title_short A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt
title_full A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt
title_fullStr A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt
title_full_unstemmed A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt
title_sort cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in egypt
publisher BMC
series BMC Pregnancy and Childbirth
issn 1471-2393
publishDate 2020-05-01
description Abstract Background Previous community-based research shows that secondary prevention of postpartum hemorrhage (PPH) with misoprostol only given to women with above-average measured blood loss produces similar clinical outcomes compared to routine administration of misoprostol for prevention of PPH. Given the difficulty of routinely measuring blood loss for all deliveries, more operational models of secondary prevention are needed. Methods This cluster-randomized, non-inferiority trial included women giving birth with nurse-midwives at home or in Primary Health Units (PHUs) in rural Egypt. Two PPH management approaches were compared: 1) 600mcg oral misoprostol given to all women after delivery (i.e. primary prevention, current standard of care); 2) 800mcg sublingual misoprostol given only to women with 350-500 ml postpartum blood loss estimated using an underpad (i.e. secondary prevention). The primary outcome was mean change in pre- and post-delivery hemoglobin. Secondary outcomes included hemoglobin ≥2 g/dL and other PPH interventions. Results Misoprostol was administered after delivery to 100% (1555/1555) and 10.7% (117/1099) of women in primary and secondary prevention clusters, respectively. The mean drop in pre- to post-delivery hemoglobin was 0.37 (SD: 0.91) and 0.45 (SD: 0.76) among women in primary and secondary prevention clusters, respectively (difference adjusted for clustering = 0.01, one-sided 95% CI: < 0.27, p = 0.535). There were no statistically significant differences in secondary outcomes, including hemoglobin drop ≥2 g/dL, PPH diagnosis, transfer to higher level, or other interventions. Conclusions Misoprostol for secondary prevention of PPH is comparable to universal prophylaxis and can be implemented using local materials, such as underpads. Trial registration Clinicaltrials.gov NCT02226588 , date of registration 27 August 2014.
topic Misoprostol
Postpartum hemorrhage
Low and middle income countries
Secondary prevention
Prophylaxis
Home-births
url http://link.springer.com/article/10.1186/s12884-020-03008-5
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