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Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
Misoprostol
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 in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent

Exclusion Criteria:

  • women with known contraindications to prostaglandins

Sites / Locations

  • Health huts in the district of Thiadiaye and Kolda

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
October 22, 2012
Last Updated
February 24, 2016
Sponsor
Gynuity Health Projects
Collaborators
ChildFund International
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1. Study Identification

Unique Protocol Identification Number
NCT01713153
Brief Title
Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal
Official Title
Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynuity Health Projects
Collaborators
ChildFund International

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, 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
1365 (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)
Misoprostol
Other Intervention Name(s)
Cytotec, Misoclear
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
Title
referrals
Description
referral requested, transfers carried out, reasons for incomplete referrals/transfers
Time Frame
0-3 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 in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent Exclusion Criteria: women with known contraindications to prostaglandins
Facility Information:
Facility Name
Health huts in the district of Thiadiaye and Kolda
City
Thiadiay and Kolda
State/Province
Thiadiaye and Kolda
Country
Senegal

12. IPD Sharing Statement

Citations:
PubMed Identifier
26718808
Citation
Diop A, Daff B, Sow M, Blum J, Diagne M, Sloan NL, Winikoff B. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial. Lancet Glob Health. 2016 Jan;4(1):e37-44. doi: 10.1016/S2214-109X(15)00219-3.
Results Reference
derived

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Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal

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