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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Gynuity Health Projects
Sponsor:
Collaborator:
Child Fund International
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01713153
First received: October 22, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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 Intervention
Postpartum Hemorrhage
Drug: Misoprostol
Device: UnijectTM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Mean change in hemoglobin [ Time Frame: during 3rd trimester and 1-3 days postpartum ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 hour postpartum ] [ Designated as safety issue: Yes ]
    nausea, vomiting, diarrhea, shivering, fever

  • correct timing of drug administration [ Time Frame: collected immediately following birth, verified 1-3 days postpartum ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: during third trimester and 1-3 days postpartum ] [ Designated as safety issue: No ]
  • additional interventions [ Time Frame: during birth ] [ Designated as safety issue: No ]
    use of additional uterotonics, manual removal of placental fragments, etc

  • referrals [ Time Frame: 0-3 days postpartum ] [ Designated as safety issue: No ]
    referral requested, transfers carried out, reasons for incomplete referrals/transfers

  • acceptability [ Time Frame: 1-3 days postpartum ] [ Designated as safety issue: No ]
    acceptability according to woman of study medication, care received, side effects experienced


Estimated Enrollment: 682
Study Start Date: June 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713153

Locations
Senegal
Health huts in the district of Thiadiaye and Kolda Recruiting
Thiadiay and Kolda, Thiadiaye and Kolda, Senegal
Contact: Mamadou Diagne    +221776342918    mdiagne@senegal.childfund.org   
Contact: Maimouna Sow    +221776357924    msow@senegal.childfund.org   
Principal Investigator: Bocar Daff         
Principal Investigator: Mamadou Diagne         
Principal Investigator: Ayisha Diop         
Principal Investigator: Jennifer Blum         
Sponsors and Collaborators
Gynuity Health Projects
Child Fund International
  More Information

Additional Information:
No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01713153     History of Changes
Other Study ID Numbers: 2.4.9
Study First Received: October 22, 2012
Last Updated: October 22, 2012
Health Authority: Senegal: Ministry of Health and Prevention

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
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 21, 2014