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

Not Applicable

Completed

• Conditions: Postpartum Haemorrhage
• Interventions: Drug: Misoprostol; Other: placebo

• Registration Number: NCT01485562
• Lead Sponsor: Gynuity Health Projects

Brief Summary

A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.

Detailed Description

A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level.

The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.

Study Timeline

• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Study Start: 2012-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Women who deliver at home with a study TBA present.
• Women must be willing and able to provide informed consent
• Women must agree to participate in a follow up interview
• Women must agree to have pre and post-partum haemoglobin taken

Exclusion Criteria

• If the woman does not meet any of the above outlined inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol	women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)
placebo	placebo	women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually

Primary Outcome Measures

Name	Time	Method
Haemoglobin concentration (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.

Secondary Outcome Measures

Name	Time	Method
number of women who found misoprostol treatment to be acceptable	immediately after delivery; 3-5 days post delivery	women will be asked to rate their acceptability with the treatment using a scale
Number of participants who experience side effects	immediately after delivery; 3-5 days post delivery	number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided
number of participants who received additional interventions	immediately after delivery; 3-5 days post delivery	number of participants who received care by as skilled provider and the type of care provided
number of participants who experience severe adverse events	immediately after delivery; 3-5 days post delivery	serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.

Trial Locations

Locations (1)

Home Births; 🇵🇰 Chitral, Khyber Pakhtunkhwa, Pakistan