Misoprostol for the Treatment of Postpartum Hemorrhage

• Need for additional treatment after initial PPH study treatment [ Time Frame: all additional interventions recorded following initial uterotonic treatment ] [ Designated as safety issue: Yes ]
  

• Mean blood loss after PPH treatment [ Time Frame: blood loss measured for minimum of 1 hour or until active bleeding ceases ] [ Designated as safety issue: Yes ]
  
• Change in hemoglobin from pre-delivery to postpartum [ Time Frame: Pe-delivery hemoblogin measured upon entry into labor ward; postpartum Hb measured 12-24 hrs after removal of IV ] [ Designated as safety issue: Yes ]
  
• Time to bleeding cessation [ Time Frame: Time to bleeding cessation recorded ] [ Designated as safety issue: Yes ]
  
• Blood transfusion [ Time Frame: any blood transfusion recorded after delivery and prior to discharge ] [ Designated as safety issue: Yes ]
  
• Side effects [ Time Frame: any observed or reported side effects recorded following treatment and prior to discharge ] [ Designated as safety issue: Yes ]
  
• Acceptability for women [ Time Frame: Exit interview conducted prior to discharge ] [ Designated as safety issue: No ]
  

Postpartum hemorrhage (PPH) remains a major cause of maternal deaths worldwide. Misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat PPH. For example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive. This randomized, double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary PPH in hospital births, both when women have received prophylactic uterotonics in the third stage of labor and when they have not.

Blood loss will be measured for all consenting women who deliver vaginally. If PPH occurs and uterine atony is the suspected cause, women will be randomized to receive either: a) four 200 µg pills of misoprostol sublingually and an IV of saline (resembling oxytocin) or b) four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV. This study seeks to answer the following questions:

• Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor?
• Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH?
• Is the side effect profile of misoprostol acceptable to women?

This study will take place in hospitals located in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam.