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Randomized Controlled Trial
. 2020 May 24;20(1):317.
doi: 10.1186/s12884-020-03008-5.

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

Holly A Anger  1 , Rasha Dabash  2 , Nevine Hassanein  3 , Emad Darwish  4 , Mohamed Cherine Ramadan  5 , Medhat Nawar  6 , Dyanna Charles  2 , Miral Breebaart  7 , Beverly Winikoff  2
Affiliations
Randomized Controlled Trial

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

Holly A Anger et al. BMC Pregnancy Childbirth. .

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.

Keywords: Home-births; Low and middle income countries; Midwives; Misoprostol; Postpartum hemorrhage; Prophylaxis; Secondary prevention; Task-sharing.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart of cluster-randomized, non-inferiority trial. Abbreviations: PHU=Primary Health Unit, Hb = hemoglobin, 1Other reasons women delivered at hospital: anemia (n = 6), cephalopelvic disproportion (n = 2), dystocia (n = 2), patient/family preference (n = 2), cord prolapse (n = 2), antepartum bleeding (n = 1), cervical stenosis (n = 1), cord wrapped around head or neck of fetus (n = 1), 2Other reasons women delivered at hospital: antepartum bleeding (n = 9), cephalopelvic disproportion (n = 6), gestation past 40 weeks (n = 4), patient/family preference (n = 2), anemia (n = 1), cervical stenosis (n = 1), cord wrapped around head or neck of fetus (n = 1), low amniotic fluid on ultrasound (n = 1), doctor’s decision (n = 1), unknown (n = 1)
Fig. 2
Fig. 2
Non-inferiority test. Both the point estimate and one 95% confidence interval for change in pre- and post-delivery hemoglobin falls above the a priori-defined non-inferiority margin of -0.3, indicating that secondary prevention is non-inferior to primary prevention. Abbreviations: CI=Confidence interval, Hb = hemoglobin, SP = secondary prevention, PP = primary prevention
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