Clinical Trial: Misoprostol in the Treatment of Postpartum Hemorrhage

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Misoprostol in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals

Brief 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.

Detailed Summary:
Sponsor: Gynuity Health Projects

Current Primary Outcome: Blood loss greater than or equal to 500 mls after enrolment [ Time Frame: Blood loss measured for minimum of 1 hour or until active bleeding ceased ]

Original Primary Outcome: Blood loss greater than or equal to 500 mls after enrolment

Current Secondary Outcome:

  • Average blood loss [ Time Frame: Blood loss measured for minimum of one hour or until active bleeding ceased ]
  • Clinical complications (need for transfusion, hysterectomy) [ Time Frame: After delivery and prior to hospital discharge ]
  • Pre-delivery and post-delivery hemoglobin measures [ Time Frame: Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery ]
  • Side effects [ Time Frame: observed or reported following study treatment and prior to discharge ]


Original Secondary Outcome:

  • Average blood loss
  • Clinical complications (need for transfusion, hysterectomy)
  • Haemoglobin 12-24 hours after delivery
  • Side effects


Information By: Gynuity Health Projects

Dates:
Date Received: June 29, 2005
Date Started: December 2005
Date Completion:
Last Updated: March 17, 2009
Last Verified: March 2009