Misoprostol for the Treatment of Postpartum Hemorrhage

Gynuity Health Projects

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Drug: Misoprostol; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT00116350

WIRB #20041878/1063615

2.4.1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,786 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,786 participants in 2 patient groups

Misoprostol

Experimental group

Description:

800 mcg sublingual misoprostol

Treatment:

Drug: Misoprostol

Oxytocin

Active Comparator group

Description:

40 IU Oxytocin IV

Treatment:

Drug: Oxytocin