Clinical Trial: Misoprostol for the Treatment of Postpartum Hemorrhage

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Misoprostol for the Treatment of Primary Postpartum Hemorrhage

Brief Summary: The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.

Detailed Summary:

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.


Sponsor: Gynuity Health Projects

Current Primary Outcome: Need for additional treatment after initial PPH study treatment [ Time Frame: all additional interventions recorded following initial uterotonic treatment ]

Original Primary Outcome: Need for additional treatment after initial PPH treatment; Comparison of misoprostol and oxytocin groups at interim analysis at one year

Current Secondary Outcome:

  • Mean blood loss after PPH treatment [ Time Frame: blood loss measured for minimum of 1 hour or until active bleeding ceases ]
  • 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 ]
  • Time to bleeding cessation [ Time Frame: Time to bleeding cessation recorded ]
  • Blood transfusion [ Time Frame: any blood transfusion recorded after delivery and prior to discharge ]
  • Side effects [ Time Frame: any observed or reported side effects recorded following treatment and prior to discharge ]
  • Acceptability for women [ Time Frame: Exit interview conducted prior to discharge ]


Original Secondary Outcome:

  • Mean blood loss after PPH treatment
  • Change in hemoglobin from pre-delivery to postpartum
  • Time to bleeding cessation
  • Blood transfusion
  • Side effects
  • Acceptability for women


Information By: Gynuity Health Projects

Dates:
Date Received: June 28, 2005
Date Started: July 2005
Date Completion:
Last Updated: March 17, 2009
Last Verified: March 2009