Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali
This study is not yet open for participant recruitment.
Verified February 2013 by Gynuity Health Projects
Sponsor:
Gynuity Health Projects
Collaborators:
Aga Khan Foundation, Mali
Guttmacher Institute
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01487278
First received: December 5, 2011
Last updated: February 25, 2013
Last verified: February 2013
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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: misprostol 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 in UnijectTM in Mali |
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 and 1-3 days postpartum ] [ Designated as safety issue: No ]use of additional uterotonics, manual removal of placental fragments, etc
- referrals [ Time Frame: 1-3 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: | 1070 |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487278
Contacts
| Contact: Laura J Frye, MPH | 212.448.1230 ext 220 | LFrye@gynuity.org |
| Contact: Ayisha R Diop, MPH | 212.448.1230 ext 222 | ADiop@gynuity.org |
Locations
| Mali | |
| Villages in Mopti | Not yet recruiting |
| Mopti, Mali | |
| Contact: Soumaigalou A Maiga +233 21.43.14.06 soumagailou.alhousseini@akdn.org | |
| Principal Investigator: Yacouba Kone, MD | |
Sponsors and Collaborators
Gynuity Health Projects
Aga Khan Foundation, Mali
Guttmacher Institute
Investigators
| Principal Investigator: | Ayisha R Diop, MPH | Gynuity Health Projects |
| Principal Investigator: | Laura J Frye, MPH | Gynuity Health Projects |
| Principal Investigator: | Yacouba Kone, M.D | Aga Khan Foundation, Mali |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT01487278 History of Changes |
| Other Study ID Numbers: | 2.4.8 |
| Study First Received: | December 5, 2011 |
| Last Updated: | February 25, 2013 |
| Health Authority: | Mali: Ministry of Health |
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 Anti-Ulcer Agents Gastrointestinal Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 19, 2013