Misoprostol for the Treatment of Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

Misoprostol for the Treatment of Primary Postpartum Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116350
• Other study ID #: 2.4.1
• Secondary ID: WIRB #20041878/1
• Status: Completed
• Phase: N/A
• First received: June 28, 2005
• Last updated: March 17, 2009
• Start date: July 2005
• Est. completion date: January 2008

Study information

• Verified date: March 2009
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1786
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Burkina Faso	Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso	Bobo Diolasso
Ecuador	Hospital Gineco-Obstetrico Isidro Ayora	Quito
Egypt	Alexandria University Hospital, Shatby Maternity Hospital	Alexandria
Egypt	El-Galaa Teaching Hospital	Cairo
Turkey	Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital	Ankara
Vietnam	Cu Chi Hospital, Tu Du Hospital, Hocmon Hospital, Binh Duong Hospital	Ho Chi Minh City and Binh Duong Province

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Family Care International

Countries where clinical trial is conducted

Burkina Faso,  Ecuador,  Egypt,  Turkey,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for additional treatment after initial PPH study treatment		all additional interventions recorded following initial uterotonic treatment	Yes
Secondary	Mean blood loss after PPH treatment		blood loss measured for minimum of 1 hour or until active bleeding ceases	Yes
Secondary	Change in hemoglobin from pre-delivery to postpartum		Pe-delivery hemoblogin measured upon entry into labor ward; postpartum Hb measured 12-24 hrs after removal of IV	Yes
Secondary	Time to bleeding cessation		Time to bleeding cessation recorded	Yes
Secondary	Blood transfusion		any blood transfusion recorded after delivery and prior to discharge	Yes
Secondary	Side effects		any observed or reported side effects recorded following treatment and prior to discharge	Yes
Secondary	Acceptability for women		Exit interview conducted prior to discharge	No

External Links

•   Gynuity Health Projects website