Misoprostol for the Treatment of Postpartum Hemorrhage

NCT00116350 | Completed DMC

• 2 other identifiers: 2.4.1WIRB #20041878/1063615
• Study Type: interventional
• Target: 1,786
• Locations: 5 countries
• Sites: 6

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.

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhage; Misoprostol; Developing countries; Maternal morbidity; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Need for additional treatment after initial PPH study treatment

  all additional interventions recorded following initial uterotonic treatment

Secondary Outcomes (6)

• 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

Study Arms (2)

Misoprostol

EXPERIMENTAL

800 mcg sublingual misoprostol

Drug: Misoprostol

Oxytocin

ACTIVE COMPARATOR

40 IU Oxytocin IV

Drug: Oxytocin

Interventions

Misoprostol DRUG

800 mcg sublingual misoprostol

Misoprostol

Oxytocin DRUG

40 IU Oxytocin IV

Oxytocin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Vaginal delivery
• Postpartum hemorrhage due to suspected uterine atony
• Depending on study group: administration of prophylactic uterotonics in third stage of labor

You may not qualify if:

• Known allergy to misoprostol or other prostaglandin
• C-section for current delivery

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Family Care International: collaborator

Study Sites (6)

Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso

Bobo Diolasso, Burkina Faso

Location

Hospital Gineco-Obstetrico Isidro Ayora

Quito, Ecuador

Location

Alexandria University Hospital, Shatby Maternity Hospital

Alexandria, Egypt

Location

El-Galaa Teaching Hospital

Cairo, Egypt

Location

Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

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

Ho Chi Minh City and Binh Duong Province, Vietnam

Location

Related Publications (3)

• 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.

  PMID: 33232518 DERIVED

• 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.

  PMID: 20060162 DERIVED

• 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.

  PMID: 20060161 DERIVED

Related Links

• Gynuity Health Projects website

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Jennifer Blum, MPH

  Gynuity Health Projects

  STUDY DIRECTOR

• Rasha Dabash, MPH

  Gynuity Health Projects

  STUDY DIRECTOR

• Sheila Raghavan, M.Sc.

  Gynuity Health Projects

  STUDY DIRECTOR

• Ayisha Diop, MPH

  Gynuity Health Projects

  STUDY DIRECTOR

• Ilana Dzuba, M.H.Sc.

  Gynuity Health Projects

  STUDY DIRECTOR

• Jill Durocher

  Gynuity Health Projects

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2005
• First Posted: June 29, 2005
• Study Start: July 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: March 19, 2009

Record last verified: 2009-03

Locations

VN (1); BU (1); EC (1); EG (2); TU (1)