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Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

Primary Purpose

Postpartum Hemorrhage

Status
Withdrawn
Phase
Not Applicable
Locations
Mali
Study Type
Interventional
Intervention
misprostol
UnijectTM
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 postpartum hemorrhage, prevention, misoprostol, Uniject, oxytocin

Eligibility Criteria

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

Inclusion Criteria:

  • women delivering at home with a trained study provider who are able to provide informed consent

Exclusion Criteria:

  • women with known contraindications to prostaglandins

Sites / Locations

  • Villages in Mopti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Misoprostol

UnijectTM

Arm Description

600 mcg oral misoprostol administered during the third stage of labor

10 IU oxytocin delivered IM with UnijectTM during he third stage of labor

Outcomes

Primary Outcome Measures

Mean change in hemoglobin
To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.

Secondary Outcome Measures

occurrence and management of side effects
nausea, vomiting, diarrhea, shivering, fever
correct timing of drug administration
administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta
change in hemoglobin ≥ 2 g/dL
additional interventions
use of additional uterotonics, manual removal of placental fragments, etc
referrals
referral requested, transfers carried out, reasons for incomplete referrals/transfers
acceptability
acceptability according to woman of study medication, care received, side effects experienced

Full Information

First Posted
December 5, 2011
Last Updated
January 8, 2014
Sponsor
Gynuity Health Projects
Collaborators
The Aga Khan Foundation, Guttmacher Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01487278
Brief Title
Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali
Official Title
Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in UnijectTM in Mali
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynuity Health Projects
Collaborators
The Aga Khan Foundation, Guttmacher Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.
Detailed Description
This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
postpartum hemorrhage, prevention, misoprostol, Uniject, oxytocin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol
Arm Type
Experimental
Arm Description
600 mcg oral misoprostol administered during the third stage of labor
Arm Title
UnijectTM
Arm Type
Experimental
Arm Description
10 IU oxytocin delivered IM with UnijectTM during he third stage of labor
Intervention Type
Drug
Intervention Name(s)
misprostol
Other Intervention Name(s)
Cytotec
Intervention Description
600 mcg misoprostol oral
Intervention Type
Device
Intervention Name(s)
UnijectTM
Intervention Description
10 IU oxytocin delivered intramuscularly with UnijectTM
Primary Outcome Measure Information:
Title
Mean change in hemoglobin
Description
To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.
Time Frame
during 3rd trimester and 1-3 days postpartum
Secondary Outcome Measure Information:
Title
occurrence and management of side effects
Description
nausea, vomiting, diarrhea, shivering, fever
Time Frame
1 hour postpartum
Title
correct timing of drug administration
Description
administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta
Time Frame
collected immediately following birth, verified 1-3 days postpartum
Title
change in hemoglobin ≥ 2 g/dL
Time Frame
during third trimester and 1-3 days postpartum
Title
additional interventions
Description
use of additional uterotonics, manual removal of placental fragments, etc
Time Frame
during birth and 1-3 days postpartum
Title
referrals
Description
referral requested, transfers carried out, reasons for incomplete referrals/transfers
Time Frame
1-3 days postpartum
Title
acceptability
Description
acceptability according to woman of study medication, care received, side effects experienced
Time Frame
1-3 days postpartum

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women delivering at home with a trained study provider who are able to provide informed consent Exclusion Criteria: women with known contraindications to prostaglandins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayisha R Diop, MPH
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura J Frye, MPH
Organizational Affiliation
Gynuity Health Projects
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yacouba Kone, M.D
Organizational Affiliation
The Aga Khan Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Villages in Mopti
City
Mopti
Country
Mali

12. IPD Sharing Statement

Learn more about this trial

Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

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