Misoprostol for the Treatment of Postpartum Hemorrhage
- Registration Number
- NCT00116350
- Lead Sponsor
- Gynuity Health Projects
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1786
- Vaginal delivery
- Postpartum hemorrhage due to suspected uterine atony
- Depending on study group: administration of prophylactic uterotonics in third stage of labor
- Known allergy to misoprostol or other prostaglandin
- C-section for current delivery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxytocin Oxytocin 40 IU Oxytocin IV Misoprostol Misoprostol 800 mcg sublingual misoprostol
- Primary Outcome Measures
Name Time Method Need for additional treatment after initial PPH study treatment all additional interventions recorded following initial uterotonic treatment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital
🇹🇷Ankara, Turkey
Hospital Gineco-Obstetrico Isidro Ayora
🇪🇨Quito, Ecuador
Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso
🇧🇫Bobo Diolasso, Burkina Faso
El-Galaa Teaching Hospital
🇪🇬Cairo, Egypt
Cu Chi Hospital, Tu Du Hospital, Hocmon Hospital, Binh Duong Hospital
🇻🇳Ho Chi Minh City and Binh Duong Province, Vietnam
Alexandria University Hospital, Shatby Maternity Hospital
🇪🇬Alexandria, Egypt