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

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage (PPH)
• Interventions: Other: placebo; Drug: Misoprostol

• Registration Number: NCT01508429
• Lead Sponsor: Gynuity Health Projects

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Study Start: 2012-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• 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

Exclusion Criteria

• Women who do not meet the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	4 placebo tablets (resembling misoprostol) administered sublingually
misoprostol	Misoprostol	800mcg misoprostol (four tablets of 200 mcg administered sublingually)

Primary Outcome Measures

Name	Time	Method
Hb of greater than or equal to 2 g/dl from pre- to post-delivery	3-5 days after 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.

Secondary Outcome Measures

Name	Time	Method
Side effects	immediately after delivery; 3-5 days post delivery	Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.
Acceptability	immediately after delivery; 3-5 days post delivery	Acceptability and management of side effects, acceptablity of taking the drugs
additional interventions	immediately after delivery; 3-5 days post delivery	Additional interventions and additional care provided to the woman, # of referrals and transfers

Trial Locations

Locations (1)

Home delivery setting; 🇦🇫 Darwaz, Ishkashim, Shugnan, Wakhan districts, Badakshan Province, Afghanistan