Misoprostol in the Treatment of Postpartum Hemorrhage

This study has been completed.
Sponsor:
Collaborators:
Aga Khan University
Aga Khan Health Services
The Aga Khan Foundation
Family Care International
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00116480
First received: June 29, 2005
Last updated: March 17, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Drug: Misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Misoprostol in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average blood loss [ Time Frame: Blood loss measured for minimum of one hour or until active bleeding ceased ] [ Designated as safety issue: Yes ]
  • Clinical complications (need for transfusion, hysterectomy) [ Time Frame: After delivery and prior to hospital discharge ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Side effects [ Time Frame: observed or reported following study treatment and prior to discharge ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: December 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Misoprostol
three tablets of active misoprostol (600 mcg) given sublingually
Drug: Misoprostol
600 mcg of sublingual misoprostol
Placebo Comparator: Placebo
three tablets resembling misoprostol given sublingually
Drug: Misoprostol
600 mcg of sublingual misoprostol

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116480

Locations
Pakistan
The Aga Khan Health Services
Karachi, Pakistan
Aga Khan University Hospital
Karachi, Pakistan
Sponsors and Collaborators
Gynuity Health Projects
Aga Khan University
Aga Khan Health Services
The Aga Khan Foundation
Family Care International
Investigators
Principal Investigator: Nadeem F Zuberi, MD Aga Khan University Hospital, Karachi
  More Information

Additional Information:
No publications provided by Gynuity Health Projects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00116480     History of Changes
Other Study ID Numbers: 2.4.2
Study First Received: June 29, 2005
Last Updated: March 17, 2009
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Gynuity Health Projects:
Postpartum Haemorrhage
Misoprostol

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on July 31, 2014