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Misoprostol for the Treatment of Postpartum Hemorrhage

This study has been completed.
Sponsor:
Collaborator:
Family Care International
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00116350
First received: June 28, 2005
Last updated: March 17, 2009
Last verified: March 2009

June 28, 2005
March 17, 2009
July 2005
January 2008   (final data collection date for primary outcome measure)
Need for additional treatment after initial PPH study treatment [ Time Frame: all additional interventions recorded following initial uterotonic treatment ] [ Designated as safety issue: Yes ]
Need for additional treatment after initial PPH treatment; Comparison of misoprostol and oxytocin groups at interim analysis at one year
Complete list of historical versions of study NCT00116350 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Misoprostol for the Treatment of Postpartum Hemorrhage
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Postpartum Hemorrhage
  • Drug: Misoprostol
    800 mcg sublingual misoprostol
  • Drug: Oxytocin
    40 IU Oxytocin IV
  • Experimental: Misoprostol
    800 mcg sublingual misoprostol
    Intervention: Drug: Misoprostol
  • Active Comparator: Oxytocin
    40 IU Oxytocin IV
    Intervention: Drug: Oxytocin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1786
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Ecuador,   Egypt,   Turkey,   Vietnam
 
NCT00116350
2.4.1, WIRB #20041878/1063615
Yes
Gynuity Health Projects
Gynuity Health Projects
Family Care International
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Jennifer Blum, MPH Gynuity Health Projects
Study Director: Rasha Dabash, MPH Gynuity Health Projects
Study Director: Sheila Raghavan, M.Sc. Gynuity Health Projects
Study Director: Ayisha Diop, MPH Gynuity Health Projects
Study Director: Ilana Dzuba, M.H.Sc. Gynuity Health Projects
Study Director: Jill Durocher Gynuity Health Projects
Gynuity Health Projects
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP