Official Title: “Misoprostol for the Treatment of Primary Postpartum Hemorrhage”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Misoprostol
  • 800 mcg sublingual misoprostol
• Drug: Oxytocin
  • 40 IU Oxytocin IV

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Misoprostol
  • 800 mcg sublingual misoprostol
• Active Comparator: Oxytocin
  • 40 IU Oxytocin IV

Primary Measures

• Need for additional treatment after initial PPH study treatment
  • Time Frame: all additional interventions recorded following initial uterotonic treatment
    Safety Issue?: Yes

Secondary Measures

• Mean blood loss after PPH treatment
  • Time Frame: blood loss measured for minimum of 1 hour or until active bleeding ceases
    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
    Safety Issue?: Yes
• Time to bleeding cessation
  • Time Frame: Time to bleeding cessation recorded
    Safety Issue?: Yes
• Blood transfusion
  • Time Frame: any blood transfusion recorded after delivery and prior to discharge
    Safety Issue?: Yes
• Side effects
  • Time Frame: any observed or reported side effects recorded following treatment and prior to discharge
    Safety Issue?: Yes
• Acceptability for women
  • Time Frame: Exit interview conducted prior to discharge
    Safety Issue?: No

Inclusion Criteria:

• Vaginal delivery
• Postpartum hemorrhage due to suspected uterine atony
• Depending on study group: administration of prophylactic uterotonics in third stage of labor

Exclusion Criteria:

• Known allergy to misoprostol or other prostaglandin
• C-section for current delivery

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Gynuity Health Projects

Overall Clinical Trial Officials and Contacts

Beverly Winikoff, MD, MPH Principal Investigator Gynuity Health Projects  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00116350

Study ID Number: 2.4.1

ClinicalTrials.gov Identifier: NCT00116350

Health Authority: United States: Institutional Review Board

Gynuity Health Projects website