Misoprostol for the Treatment of Postpartum Hemorrhage

Sponsor

Gynuity Health Projects (Other)

Overall Status

Completed

CT.gov ID

NCT00116350

Collaborator

Family Care International (Other)

1,786

Enrollment

Locations

Arms

Duration (Months)

297.7

Patients Per Site

9.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage	Drug: Misoprostol Drug: Oxytocin	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1786 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Misoprostol for the Treatment of Primary Postpartum Hemorrhage

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Misoprostol 800 mcg sublingual misoprostol	Drug: Misoprostol 800 mcg sublingual misoprostol
Active Comparator: Oxytocin 40 IU Oxytocin IV	Drug: Oxytocin 40 IU Oxytocin IV

Arm

Intervention/Treatment

Experimental: Misoprostol

800 mcg sublingual misoprostol

Drug: Misoprostol

800 mcg sublingual misoprostol

Active Comparator: Oxytocin

40 IU Oxytocin IV

Drug: Oxytocin

40 IU Oxytocin IV

Outcome Measures

Primary Outcome Measures

Need for additional treatment after initial PPH study treatment [all additional interventions recorded following initial uterotonic treatment]

Secondary Outcome Measures

Mean blood loss after PPH treatment [blood loss measured for minimum of 1 hour or until active bleeding ceases]
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]
Time to bleeding cessation [Time to bleeding cessation recorded]
Blood transfusion [any blood transfusion recorded after delivery and prior to discharge]
Side effects [any observed or reported side effects recorded following treatment and prior to discharge]
Acceptability for women [Exit interview conducted prior to discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso	Bobo Diolasso	Burkina Faso
2	Hospital Gineco-Obstetrico Isidro Ayora	Quito	Ecuador
3	Alexandria University Hospital, Shatby Maternity Hospital	Alexandria	Egypt
4	El-Galaa Teaching Hospital	Cairo	Egypt
5	Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital	Ankara	Turkey	06010
6	Cu Chi Hospital, Tu Du Hospital, Hocmon Hospital, Binh Duong Hospital	Ho Chi Minh City and Binh Duong Province	Vietnam