title: Randomized controlled trial comparing 200μg and 400μg sublingual misoprostol for prevention of primary postpartum hemorrhage.
abstract: OBJECTIVE
  To compare efficacy and adverse effects of 200μg and 400μg misoprostol for prevention of postpartum hemorrhage (PPH).
  
  
  METHODS
  In a randomized control trial, women with term singleton pregnancies in active labor attending University College Hospital, Ibadan, Nigeria, were enrolled between July 2011 and February 2012. Participants were randomly assigned using random numbers (block size four) to receive 200μg or 400μg sublingual misoprostol after delivery of the anterior shoulder, alongside intravenous oxytocin. Investigators were masked to group assignment, but participants were not. The primary outcomes were blood loss up to 1h after delivery, PPH (blood loss ≥500mL), and adverse effects.
  
  
  RESULTS
  Overall, 62 patients were assigned to each group. No significant differences between the 200-μg and 400-μg groups were recorded in mean peripartum blood loss (307±145mL vs 296±151mL; P=0.679) and PPH occurrence (5 [8.1%] vs 6 [9.7%] women; P=0.752). Noticeable adverse effects were reported by 16 (25.8%) women in the 200-μg group and 42 (67.7%) in the 400-μg group (P<0.001). Risk of shivering was significantly lower with 200μg than 400μg (relative risk 0.33, 95% confidence interval 0.19-0.58).
  
  
  CONCLUSIONS
  Blood loss and PPH occurrence did not differ by misoprostol dose, but a 200-μg dose was associated with a reduction in adverse effects. Pan Africa Clinical Trials Registry: PACTR201505001107182.
authors.affiliation: Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria.
authors.forename: Innocent A
authors.initials: IA
authors.lastname: Ugwu
authors.affiliation: Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria; Department of Obstetrics and Gynecology, College of Medicine, University of Ibadan, Ibadan, Nigeria. Electronic address: sesanoluwasola@yahoo.com.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Oluwasola
authors.affiliation: Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria.
authors.forename: Obehi O
authors.initials: OO
authors.lastname: Enabor
authors.affiliation: Department of Hematology, University College Hospital, Ibadan, Nigeria.
authors.forename: Ngozi N
authors.initials: NN
authors.lastname: Anayochukwu-Ugwu
authors.affiliation: Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria.
authors.forename: Abolaji B
authors.initials: AB
authors.lastname: Adeyemi
authors.affiliation: Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria; Department of Obstetrics and Gynecology, College of Medicine, University of Ibadan, Ibadan, Nigeria.
authors.forename: Oladapo O
authors.initials: OO
authors.lastname: Olayemi
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D009549:Nigeria; D010120:Oxytocics / Q000008:administration & dosage* / Q000009:adverse effects; D010121:Oxytocin / Q000008:administration & dosage* / Q000009:adverse effects; D006473:Postpartum Hemorrhage / Q000517:prevention & control*; D011247:Pregnancy; D012768:Shivering; D062606:Tertiary Care Centers; D016896:Treatment Outcome
chemical_list: D010120:Oxytocics; D016595:Misoprostol; D010121:Oxytocin
keywords: Adverse effects; Misoprostol; Postpartum hemorrhage; Sublingual