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

NCT01508429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-07-11

No results posted yet for this study

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)

Interventions

OTHER

placebo

4 placebo tablets (resembling misoprostol) administered sublingually

DRUG

Misoprostol

800mcg misoprostol (4 200mcg tablets administered sublingually)

Sponsors & Collaborators

  • Aga Khan Health Services

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Shafiq Mirzazada · Aga Khan Health Services

  • Gijs Walraven · Secretariat of His Highness the Aga Khan, Aiglemont

  • Dina Abbas · Gynuity Health Projects

  • Jill Durocher · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Afghanistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01508429 on ClinicalTrials.gov