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....
Main Authors: | , , , , , , , , |
---|---|
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 |
id |
doaj-3c82fe6a500d4fbab04dc647a4f8ffca |
---|---|
record_format |
Article |
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 |
work_keys_str_mv |
AT hollyaanger aclusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT rashadabash aclusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT nevinehassanein aclusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT emaddarwish aclusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT mohamedcherineramadan aclusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT medhatnawar aclusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT dyannacharles aclusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT miralbreebaart aclusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT beverlywinikoff aclusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT hollyaanger clusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT rashadabash clusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT nevinehassanein clusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT emaddarwish clusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT mohamedcherineramadan clusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT medhatnawar clusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT dyannacharles clusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT miralbreebaart clusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt AT beverlywinikoff clusterrandomizednoninferioritytrialcomparinguseofmisoprostolforuniversalprophylaxisvssecondarypreventionofpostpartumhemorrhageamongcommunitylevelbirthsinegypt |
_version_ |
1724563472784556032 |