The MamaMiso study of self-administered misoprostol to prevent bleeding after childbirth in rural Uganda: a community-based, placebo-controlled randomised trial

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dc.contributor.authorWeeks, Andrew D.
dc.contributor.authorDitai, James
dc.contributor.authorOnonge, Sam
dc.contributor.authorFaragher, Brian
dc.contributor.authorFrye, Laura J.
dc.contributor.authorDurocher, Jill
dc.contributor.authorMirembe, Florence M.
dc.contributor.authorByamugisha, Josaphat
dc.contributor.authorWinikoff, Beverly
dc.contributor.authorAlfirevic, Zarko
dc.date.accessioned2022-08-22T19:49:53Z
dc.date.available2022-08-22T19:49:53Z
dc.date.issued2015
dc.description.abstract600 mcg of oral misoprostol reduces the incidence of postpartum haemorrhage (PPH), but in previous research this medication has been administered by health workers. It is unclear whether it is also safe and effective when self-administered by women. Methods: This placebo-controlled, double-blind randomised trial enrolled consenting women of at least 34 weeks gestation, recruited over a 2-month period in Mbale District, Eastern Uganda. Participants had their haemoglobin measured antenatally and were given either 600mcg misoprostol or placebo to take home and use immediately after birth in the event of delivery at home. The primary clinical outcome was the incidence of fall in haemoglobin of over 20 % in home births followed-up within 5 days. Results: 748 women were randomised to either misoprostol (374) or placebo (374). Of those enrolled, 57 % delivered at a health facility and 43 % delivered at home. 82 % of all medicine packs were retrieved at postnatal follow-up and 97 % of women delivering at home reported self-administration of the medicine. Two women in the misoprostol group took the study medication antenatally without adverse effects. There was no significant difference between the study groups in the drop of maternal haemoglobin by >20 % (misoprostol 9.4 % vs placebo 7.5 %, risk ratio 1.11, 95 % confidence interval 0.717 to 1.719). There was significantly more fever and shivering in the misoprostol group, but women found the medication highly acceptable. Conclusions: This study has shown that antenatally distributed, self-administered misoprostol can be appropriately taken by study participants. The rarity of the primary outcome means that a very large sample size would be required to demonstrate clinical effectiveness.en_US
dc.identifier.citationWeeks, A. D., Ditai, J., Ononge, S., Faragher, B., Frye, L. J., Durocher, J., ... & Alfirevic, Z. (2015). The MamaMiso study of self-administered misoprostol to prevent bleeding after childbirth in rural Uganda: a community-based, placebo-controlled randomised trial. BMC Pregnancy and Childbirth, 15(1), 1-10. DOI 10.1186/s12884-015-0650-9en_US
dc.identifier.other10.1186/s12884-015-0650-9
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/4371
dc.language.isoenen_US
dc.publisherBMC Pregnancy and Childbirthen_US
dc.subjectMamaMiso studyen_US
dc.subjectMisoprostolen_US
dc.subjectChildbirthen_US
dc.subjectRural Ugandaen_US
dc.titleThe MamaMiso study of self-administered misoprostol to prevent bleeding after childbirth in rural Uganda: a community-based, placebo-controlled randomised trialen_US
dc.typeArticleen_US
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