title: The MamaMiso study of self-administered misoprostol to prevent bleeding after childbirth in rural Uganda: a community-based, placebo-controlled randomised trial.
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.
  
  
  BACKGROUND
  This study was registered with the ISRCTN Register (ISRCTN70408620).
authors.affiliation: Sanyu Research Unit, Department of Women's and Children's Health, University of Liverpool, Liverpool Women's Hospital, Crown Street, Liverpool, L8 7SS, UK. aweeks@liv.ac.uk.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Weeks
authors.affiliation: Sanyu Africa Research Institute (SAfRI), Mbale Regional Referral Hospital; and Sanyu Research Unit, Department of Women's and Children's Health, University of Liverpool, Liverpool Women's Hospital, Crown Street, Liverpool, L8 7SS, UK. mocmjjd2@liverpool.ac.uk.
authors.forename: James
authors.initials: J
authors.lastname: Ditai
authors.affiliation: Department of Obstetrics and Gynaecology, Makerere University College of Health Science, P.O Box 7072, Kampala, Uganda. ononge2006@yahoo.com.
authors.forename: Sam
authors.initials: S
authors.lastname: Ononge
authors.affiliation: Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK. Brian.Faragher@lstmed.ac.uk.
authors.forename: Brian
authors.initials: B
authors.lastname: Faragher
authors.affiliation: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY, 10010, USA. lfrye@gynuity.org.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Frye
authors.affiliation: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY, 10010, USA. jdurocher@gynuity.org.
authors.forename: Jill
authors.initials: J
authors.lastname: Durocher
authors.affiliation: Department of Obstetrics and Gynaecology, Makerere University College of Health Science, P.O Box 7072, Kampala, Uganda. flomir2002@yahoo.com.
authors.forename: Florence M
authors.initials: FM
authors.lastname: Mirembe
authors.affiliation: Department of Obstetrics and Gynaecology, Makerere University College of Health Science, P.O Box 7072, Kampala, Uganda. jbyamugisha@gmail.com.
authors.forename: Josaphat
authors.initials: J
authors.lastname: Byamugisha
authors.affiliation: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY, 10010, USA. BWinikoff@gynuity.org.
authors.forename: Beverly
authors.initials: B
authors.lastname: Winikoff
authors.affiliation: Department of Women's and Children's Health, University of Liverpool, Liverpool Women's Hospital, Crown Street, Liverpool, L8 7SS, UK. zarko@liv.ac.uk.
authors.forename: Zarko
authors.initials: Z
authors.lastname: Alfirevic
mesh_terms: D000328:Adult; D036861:Delivery, Obstetric / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006454:Hemoglobins / Q000032:analysis; D006700:Home Childbirth / Q000706:statistics & numerical data*; D006801:Humans; D015994:Incidence; D016595:Misoprostol / Q000008:administration & dosage*; D010120:Oxytocics / Q000008:administration & dosage*; D006473:Postpartum Hemorrhage / Q000453:epidemiology / Q000517:prevention & control*; D011247:Pregnancy; D012424:Rural Population; D012646:Self Administration; D014454:Uganda / Q000453:epidemiology
chemical_list: D006454:Hemoglobins; D010120:Oxytocics; D016595:Misoprostol