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

Gynuity Health Projects

Status: Completed

Conditions: Postpartum Haemorrhage

Treatments: Drug: Misoprostol; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01485562

2.4.15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

84 participants in 2 patient groups, including a placebo group

Misoprostol

Active Comparator group

Description:

women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)

Treatment:

Drug: Misoprostol

placebo

Placebo Comparator group

Description:

women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually

Treatment:

Other: placebo