Postpartum Hemorrhage (PPH) Clinical Trial
Official title:
Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05542043 -
Risk Factors for Postpartum Hemorrhage in Patients With Histologically Verified Placenta Accreta
|