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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01713153
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : February 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Postpartum Hemorrhage Drug: Misoprostol Device: UnijectTM

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal
Study Start Date : June 2012
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Misoprostol
600 mcg oral misoprostol administered during the third stage of labor
Drug: Misoprostol
600 mcg misoprostol oral
Other Names:
  • Cytotec
  • Misoclear
Experimental: UnijectTM
10 IU oxytocin delivered IM with UnijectTM during he third stage of labor
Device: UnijectTM
10 IU oxytocin delivered intramuscularly with UnijectTM


Outcome Measures

Primary Outcome Measures :
  1. Mean change in hemoglobin [ Time Frame: during 3rd trimester and 1-3 days postpartum ]
    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 :
  1. Occurrence and management of side effects [ Time Frame: 1 hour postpartum ]
    nausea, vomiting, diarrhea, shivering, fever

  2. correct timing of drug administration [ Time Frame: collected immediately following birth, verified 1-3 days postpartum ]
    administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta

  3. change in hemoglobin ≥ 2 g/dL [ Time Frame: during third trimester and 1-3 days postpartum ]
  4. additional interventions [ Time Frame: during birth ]
    use of additional uterotonics, manual removal of placental fragments, etc

  5. referrals [ Time Frame: 0-3 days postpartum ]
    referral requested, transfers carried out, reasons for incomplete referrals/transfers

  6. acceptability [ Time Frame: 1-3 days postpartum ]
    acceptability according to woman of study medication, care received, side effects experienced


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713153


Locations
Senegal
Health huts in the district of Thiadiaye and Kolda
Thiadiay and Kolda, Thiadiaye and Kolda, Senegal
Sponsors and Collaborators
Gynuity Health Projects
ChildFund International
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01713153     History of Changes
Other Study ID Numbers: 2.4.9
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

Keywords provided by Gynuity Health Projects:
postpartum hemorrhage
prevention
misoprostol
Uniject
oxytocin

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