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Completed

NCT Number: NCT00116480

Misoprostol in the Treatment of Postpartum Hemorrhage

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University Hospital, Karachi, Pakistan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All women delivering vaginally with clinically diagnosed PPH requiring uterotonics

Exclusion criteria

  • Refusal to give consent for participation or if the woman is too distressed to give consent
  • Woman is not entitled to give informed consent (e.g. minors without a guardian)
  • Woman who had a caesarean section
  • Delivery is regarded as abortion (gestational age < 28 weeks)

Treatment and study plan

Misoprostol

Drug

600 mcg of sublingual misoprostol

Primary outcomes

  1. 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

Secondary outcomes

  1. Average blood loss

    Time frame: Blood loss measured for minimum of one hour or until active bleeding ceased

  2. Clinical complications (need for transfusion, hysterectomy)

    Time frame: After delivery and prior to hospital discharge

  3. 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

  4. Side effects

    Time frame: observed or reported following study treatment and prior to discharge

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Aga Khan Health Services
  • Aga Khan University
  • Family Care International
  • The Aga Khan Foundation

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 30, 2005
Registry last updated
Mar 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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