Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births

NCT01508429 | Completed DMC

• 1 other identifier: 2.4.14
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use. A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta. Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.

Conditions

Postpartum Hemorrhage (PPH)

Keywords

Postpartum hemorrhage; PPH; misoprostol; home deliveries

Outcome Measures

Primary Outcomes (1)

• Hb of greater than or equal to 2 g/dl from pre- to post-delivery

  The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. The outcome will be compared between the two treatment groups.

  3-5 days after delivery

Secondary Outcomes (3)

• Side effects

  immediately after delivery; 3-5 days post delivery

• additional interventions

  immediately after delivery; 3-5 days post delivery

• Acceptability

  immediately after delivery; 3-5 days post delivery

Study Arms (2)

misoprostol

ACTIVE COMPARATOR

800mcg misoprostol (four tablets of 200 mcg administered sublingually)

Drug: Misoprostol

placebo

PLACEBO COMPARATOR

4 placebo tablets (resembling misoprostol) administered sublingually

Other: placebo

Interventions

placebo OTHER

4 placebo tablets (resembling misoprostol) administered sublingually

placebo

Misoprostol DRUG

800mcg misoprostol (4 200mcg tablets administered sublingually)

misoprostol

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women must be pregnant
• Must be able to provide informed consent
• Must agree to have a community health worker present at the time of delivery
• Must agree to participate in a follow up interview by the study midwife
• Must agree to have pre and postpartum haemoglobin taken

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Aga Khan Health Services: collaborator

Study Sites (1)

Home delivery setting

Darwaz, Ishkashim, Shugnan, Wakhan Districts, Badakshan Province, Afghanistan

Location

Related Publications (2)

• 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

• Abbas DF, Mirzazada S, Durocher J, Pamiri S, Byrne ME, Winikoff B. Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan. Reprod Health. 2020 Jun 5;17(1):88. doi: 10.1186/s12978-020-00933-8.

  PMID: 32503556 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

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

Study Officials

• Shafiq Mirzazada

  Aga Khan Health Services

  PRINCIPAL INVESTIGATOR

• Gijs Walraven

  Secretariat of His Highness the Aga Khan, Aiglemont

  STUDY DIRECTOR

• Dina Abbas

  Gynuity Health Projects

  STUDY DIRECTOR

• Jill Durocher

  Gynuity Health Projects

  STUDY DIRECTOR

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: December 1, 2011
• First Posted: January 12, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

AF (1)