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

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. Identifier: NCT01487278
Recruitment Status : Withdrawn
First Posted : December 7, 2011
Last Update Posted : January 9, 2014
The Aga Khan Foundation
Guttmacher Institute
Information provided by (Responsible Party):
Gynuity Health Projects

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 Phase
Postpartum Hemorrhage Drug: misprostol Device: UnijectTM Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 in UnijectTM in Mali

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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 and 1-3 days postpartum ]
    use of additional uterotonics, manual removal of placental fragments, etc

  5. referrals [ Time Frame: 1-3 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

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

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

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 identifier (NCT number): NCT01487278

Villages in Mopti
Mopti, Mali
Sponsors and Collaborators
Gynuity Health Projects
The Aga Khan Foundation
Guttmacher Institute
Principal Investigator: Ayisha R Diop, MPH Gynuity Health Projects
Principal Investigator: Laura J Frye, MPH Gynuity Health Projects
Principal Investigator: Yacouba Kone, M.D The Aga Khan Foundation

Additional Information:
Responsible Party: Gynuity Health Projects Identifier: NCT01487278     History of Changes
Other Study ID Numbers: 2.4.8
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by Gynuity Health Projects:
postpartum hemorrhage

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