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

G

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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