Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Sep 14:15:219.
doi: 10.1186/s12884-015-0650-9.

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

Andrew D Weeks  1 , James Ditai  2 , Sam Ononge  3 , Brian Faragher  4 , Laura J Frye  5 , Jill Durocher  6 , Florence M Mirembe  7 , Josaphat Byamugisha  8 , Beverly Winikoff  9 , Zarko Alfirevic  10
Affiliations
Randomized Controlled Trial

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

Andrew D Weeks et al. BMC Pregnancy Childbirth. .

Abstract

Background: 600 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 600 mcg 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.

Trial registration: This study was registered with the ISRCTN Register (ISRCTN70408620).

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Pictorial instructions on how to take the tablets given to women antenatally along with the medicine packet (the first page had detailed instructions on study procedures)
Fig. 2
Fig. 2
CONSORT trial profile
See this image and copyright information in PMC

References

    1. Say L, Chou D, Gemmill A, Tunçalp Ö, Moller AB, Daniels J, et al. Global causes of maternal death: a WHO systematic analysis. The Lancet Glob Health. 2014;2:e323–e333. doi: 10.1016/S2214-109X(14)70227-X. - DOI - PubMed
    1. Hundley VA, Avan BI, Sullivan CJ, Graham WJ. Should oral misoprostol be used to prevent postpartum haemorrhage in home-birth settings in low-resource countries? A systematic review of the evidence. BJOG. 2013;120:277–285. doi: 10.1111/1471-0528.12049. - DOI - PubMed
    1. Smith JM, Gubin R, Holston MM, Fullerton J, Prata N. Misoprostol for postpartum hemorrhage prevention at home birth: an integrative review of global implementation experience to date. BMC Pregnancy Childbirth. 2013;13:44. doi: 10.1186/1471-2393-13-44. - DOI - PMC - PubMed
    1. Sanghvi H, Ansari N, Prata NJ, Gibson H, Ehsan AT, Smith JM. Prevention of postpartum hemorrhage at home birth in Afghanistan. Int J Gynaecol Obstet. 2010;108:276–281. doi: 10.1016/j.ijgo.2009.12.003. - DOI - PubMed
    1. Rajbhandari S, Hodgins S, Sanghvi H, McPherson R, Pradhan YV, Baqui AH, et al. Expanding uterotonic protection following childbirth through community-based distribution of misoprostol: Operations research study in Nepal. Int J Gynaecol Obstet. 2010;108:282–288. doi: 10.1016/j.ijgo.2009.11.006. - DOI - PubMed

Publication types

Associated data

LinkOut - more resources