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Completed

NCT Number: NCT00116350

Misoprostol for the Treatment of 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.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso, Bobo Diolasso, Burkina Faso

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

800 mcg sublingual misoprostol

Oxytocin

Drug

40 IU Oxytocin IV

Primary outcomes

  1. Need for additional treatment after initial PPH study treatment

    Time frame: all additional interventions recorded following initial uterotonic treatment

Secondary outcomes

  1. Mean blood loss after PPH treatment

    Time frame: blood loss measured for minimum of 1 hour or until active bleeding ceases

  2. 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

  3. Time to bleeding cessation

    Time frame: Time to bleeding cessation recorded

  4. Blood transfusion

    Time frame: any blood transfusion recorded after delivery and prior to discharge

  5. Side effects

    Time frame: any observed or reported side effects recorded following treatment and prior to discharge

  6. Acceptability for women

    Time frame: Exit interview conducted prior to discharge

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Family Care International

Registry information

Official study title

Misoprostol for the Treatment of Primary Postpartum Hemorrhage

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jun 29, 2005
Registry last updated
Mar 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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