Clinical trial NCT00116350: Misoprostol for the Treatment of Postpartum Hemorrhage
Official title: Misoprostol for the Treatment of Primary Postpartum Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Postpartum hemorrhage
Misoprostol
Developing countries
Maternal morbidity
Randomized controlled trial
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Family Care International
First posted: 2005-06-29
Enrollment: 1786
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for additional treatment after initial PPH study treatment
timeFrame: all additional interventions recorded following initial uterotonic treatment
Secondary outcomes:
measure: Mean blood loss after PPH treatment
timeFrame: blood loss measured for minimum of 1 hour or until active bleeding ceases
measure: Change in hemoglobin from pre-delivery to postpartum
timeFrame: Pe-delivery hemoblogin measured upon entry into labor ward; postpartum Hb measured 12-24 hrs after removal of IV
measure: Time to bleeding cessation
timeFrame: Time to bleeding cessation recorded
measure: Blood transfusion
timeFrame: any blood transfusion recorded after delivery and prior to discharge
measure: Side effects
timeFrame: any observed or reported side effects recorded following treatment and prior to discharge
measure: Acceptability for women
timeFrame: Exit interview conducted prior to discharge
Other outcomes:
Locations:
city: Bobo Diolasso
country: Burkina Faso
facility: Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso
city: Quito
country: Ecuador
facility: Hospital Gineco-Obstetrico Isidro Ayora
city: Alexandria
country: Egypt
facility: Alexandria University Hospital, Shatby Maternity Hospital
city: Cairo
country: Egypt
facility: El-Galaa Teaching Hospital
city: Ankara
country: Turkey
facility: Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital
city: Ho Chi Minh City and Binh Duong Province
country: Vietnam
facility: Cu Chi Hospital, Tu Du Hospital, Hocmon Hospital, Binh Duong Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Jennifer Blum, MPH
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Rasha Dabash, MPH
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Sheila Raghavan, M.Sc.
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Ayisha Diop, MPH
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Ilana Dzuba, M.H.Sc.
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Jill Durocher
role: STUDY_DIRECTOR
References:
citation: Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
citation: Blum J, Winikoff B, Raghavan S, Dabash R, Ramadan MC, Dilbaz B, Dao B, Durocher J, Yalvac S, Diop A, Dzuba IG, Ngoc NT. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):217-23. doi: 10.1016/S0140-6736(09)61923-1. Epub 2010 Jan 6.
citation: Winikoff B, Dabash R, Durocher J, Darwish E, Nguyen TN, Leon W, Raghavan S, Medhat I, Huynh TK, Barrera G, Blum J. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):210-6. doi: 10.1016/S0140-6736(09)61924-3. Epub 2010 Jan 6.