Misoprostol for Treatment of Postpartum Hemorrhage at Community-level Births in Egypt

NCT01619072 | Completed DMC

• 1 other identifier: 3001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled community-based trial will assess the effectiveness of administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with standard of care for postpartum hemorrhage treatment at the community level, primarily home births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this setting is referral to a higher level health facility.

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhage; treatment; misoprostol; home births

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery.

  Proportion of women with a change in hemoglobin of \>2 g/dL pre- to post-delivery, as measured by the HemoCue machine at both time points.

  Before delivery (at onset of labor), after delivery (2 to 4 days after delivery)

Secondary Outcomes (5)

• Proportion of women transferred to higher level care

  Within 2 to 4 days after delivery

• Proportion of women receiving additional interventions to treat PPH

  Within 2 to 4 days after delivery

• Proportion of women with side effects

  Within 24 hours of delivery

• Cost-effectiveness

  Within 2 to 4 days after delivery

• Proportion of women for whom intervention was correctly administered

  Within 1 hour of PPH diagnosis

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

800 mcg sublingual misoprostol + referral to higher level care

Other: Misoprostol + referral

Placebo

PLACEBO COMPARATOR

Placebo + referral to higher level care

Other: Placebo + referral

Interventions

Misoprostol + referral OTHER

800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)

Misoprostol

Placebo + referral OTHER

Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women delivering with provider from participating primary health unit (PHU)
• willing and able to give informed consent
• vaginal delivery

You may not qualify if:

• women too advanced into active labor to provide informed consent
• known allergy to misoprostol and/or other prostaglandin
• women presenting with pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, antepartum hemorrhage, previous complication in the third trimester (should be referred to higher level care for delivery)

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Ministry of Health and Population, Egypt: collaborator
• El Galaa Teaching Hospital: collaborator
• Alexandria University: collaborator

Study Sites (1)

Prinary Health Units

Etay El Barood and Kafr El Dawar Districts, Beheira, Egypt

Location

Related Publications (1)

• 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

Related Links

• Related Info

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; Referral and Consultation

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; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Mohamed Cherine Ramadan, MD

  El Galaa Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Nevine Hassanein, MD

  Consultant

  PRINCIPAL INVESTIGATOR

• Emad Darwish, MD

  Alexandria University Faculy of Medicine

  PRINCIPAL INVESTIGATOR

• Emad Ezzat, MD

  Ministry of health and population

  PRINCIPAL INVESTIGATOR

• Rasha Dabash, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

EG (1)