Misoprostol in the Treatment of Postpartum Hemorrhage
Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment
with conventional methods. Uncontrolled reports and three small randomised controlled trials
have suggested that misoprostol may have an additive effect to routine treatment, and there
is a serious danger that this method will be used widely without research to document the
effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose
to test whether 600 μg of sublingually administered misoprostol in women requiring additional
uterotonics after delivery, and after routine syntocinon to all women during or after
delivery, has additional effects above the additional conventional uterotonics in reducing
PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals
who give consent will be given locally routine treatment for PPH. In addition, they will be
enrolled by drawing the next of a series of randomised treatment packs containing misoprostol
or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls
after enrolment.
Phase:
N/A
Details
Lead Sponsor:
Gynuity Health Projects
Collaborators:
Aga Khan Health Services Aga Khan University Family Care International The Aga Khan Foundation