Misoprostol for the Treatment of Postpartum Hemorrhage

NCT ID: NCT00116350

Last Updated: 2009-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1786 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-01-31

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.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Misoprostol

800 mcg sublingual misoprostol

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

800 mcg sublingual misoprostol

Oxytocin

40 IU Oxytocin IV

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

40 IU Oxytocin IV

Interventions

Misoprostol

800 mcg sublingual misoprostol

Intervention Type: DRUG

Oxytocin

40 IU Oxytocin IV

Intervention Type: DRUG

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Family Care International

OTHER

Sponsor Role: collaborator

Gynuity Health Projects

OTHER

Sponsor Role: lead

Responsible Party

Gynuity Health Projects

Principal Investigators

Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Jennifer Blum, MPH

Role: STUDY_DIRECTOR

Gynuity Health Projects

Rasha Dabash, MPH

Role: STUDY_DIRECTOR

Gynuity Health Projects

Sheila Raghavan, M.Sc.

Role: STUDY_DIRECTOR

Gynuity Health Projects

Ayisha Diop, MPH

Role: STUDY_DIRECTOR

Gynuity Health Projects

Ilana Dzuba, M.H.Sc.

Role: STUDY_DIRECTOR

Gynuity Health Projects

Jill Durocher

Role: STUDY_DIRECTOR

Gynuity Health Projects

Locations

Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso

Bobo Diolasso, , Burkina Faso

Hospital Gineco-Obstetrico Isidro Ayora

Quito, , Ecuador

Alexandria University Hospital, Shatby Maternity Hospital

Alexandria, , Egypt

El-Galaa Teaching Hospital

Cairo, , Egypt

Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital

Ankara, , Turkey (Türkiye)

Cu Chi Hospital, Tu Du Hospital, Hocmon Hospital, Binh Duong Hospital

Ho Chi Minh City and Binh Duong Province, , Vietnam

Countries

Burkina Faso; Ecuador; Egypt; Turkey (Türkiye); Vietnam

References

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.

Reference Type: DERIVED

PMID: 33232518 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20060162 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20060161 (View on PubMed)

Related Links

http://www.gynuity.org

Gynuity Health Projects website

Other Identifiers

WIRB #20041878/1063615

Identifier Type: -

Identifier Source: secondary_id

2.4.1

Identifier Type: -

Identifier Source: org_study_id