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Misoprostol for Preventing Postpartum Hemorrhage

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
misoprostol
placebo
Sponsored by
Gynuity Health Projects
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Misoprostol, Active management, Postpartum hemorrhage, Maternal morbidity, Anemia, Developing countries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women who have given birth to 1 or more live-born infants (para 1 or more) Vaginal delivery Exclusion Criteria: Refusal or inability to give informed consent Delivery regarded as abortion according to local gestational age limits Inability to take misoprostol sublingually Cesarean section Assisted vaginal delivery

Sites / Locations

  • University College Hospital
  • Tembisa Hospital
  • Rob Ferreira Hospital
  • Dora Nginza Hospital
  • Mulago Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

placebo resembling misoprostol

misoprostol

Outcomes

Primary Outcome Measures

Blood loss =>500 mls within one hour after enrollment

Secondary Outcome Measures

Blood loss =>1000 mls within one hour after enrollment
Mean blood loss after enrollment
Blood transfusion
Hemoglobin level <8 g/dL 24 hours after delivery
Maternal morbidity and mortality
Side effects

Full Information

First Posted
July 26, 2005
Last Updated
May 26, 2008
Sponsor
Gynuity Health Projects
Collaborators
University of Witwatersrand, South Africa, Effective Care Research Unit, Family Care International
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1. Study Identification

Unique Protocol Identification Number
NCT00124540
Brief Title
Misoprostol for Preventing Postpartum Hemorrhage
Official Title
Misoprostol for Preventing Postpartum Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gynuity Health Projects
Collaborators
University of Witwatersrand, South Africa, Effective Care Research Unit, Family Care International

4. Oversight

5. Study Description

Brief Summary
This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Misoprostol, Active management, Postpartum hemorrhage, Maternal morbidity, Anemia, Developing countries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo resembling misoprostol
Arm Title
2
Arm Type
Experimental
Arm Description
misoprostol
Intervention Type
Drug
Intervention Name(s)
misoprostol
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo resembling misoprosotl
Primary Outcome Measure Information:
Title
Blood loss =>500 mls within one hour after enrollment
Secondary Outcome Measure Information:
Title
Blood loss =>1000 mls within one hour after enrollment
Title
Mean blood loss after enrollment
Title
Blood transfusion
Title
Hemoglobin level <8 g/dL 24 hours after delivery
Title
Maternal morbidity and mortality
Title
Side effects

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women who have given birth to 1 or more live-born infants (para 1 or more) Vaginal delivery Exclusion Criteria: Refusal or inability to give informed consent Delivery regarded as abortion according to local gestational age limits Inability to take misoprostol sublingually Cesarean section Assisted vaginal delivery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindeka Mangesi
Organizational Affiliation
Effective Care Research Unit, East London Hospital Complex, South Africa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
G. J. Hofmeyr, MD
Organizational Affiliation
Effective Care Research Unit, Frere Maternity Hospital, East London Hospital Complex
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital
City
Ibadan
Country
Nigeria
Facility Name
Tembisa Hospital
City
Johannesburg
Country
South Africa
Facility Name
Rob Ferreira Hospital
City
Nelspruit
Country
South Africa
Facility Name
Dora Nginza Hospital
City
Port Elizabeth
Country
South Africa
Facility Name
Mulago Hospital
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
21130990
Citation
Hofmeyr GJ, Fawole B, Mugerwa K, Godi NP, Blignaut Q, Mangesi L, Singata M, Brady L, Blum J. Administration of 400 mug of misoprostol to augment routine active management of the third stage of labor. Int J Gynaecol Obstet. 2011 Feb;112(2):98-102. doi: 10.1016/j.ijgo.2010.08.019. Epub 2010 Dec 4.
Results Reference
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Misoprostol for Preventing Postpartum Hemorrhage

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