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

Gynuity Health Projects

Status: Completed

Conditions: Postpartum Hemorrhage (PPH)

Treatments: Drug: Misoprostol; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01508429

2.4.14

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

misoprostol

Active Comparator group

Description:

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

Treatment:

Drug: Misoprostol

placebo

Placebo Comparator group

Description:

4 placebo tablets (resembling misoprostol) administered sublingually

Treatment:

Other: placebo