Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Gynuity Health Projects.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Gynuity Health Projects
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
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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: 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:
|
|
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
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:
|
Postpartum Hemorrhage Puerperal Disorders Hemorrhage Obstetric Labor Complications Pathologic Processes Pregnancy Complications Uterine Hemorrhage Misoprostol Oxytocin |
Abortifacient Agents Abortifacient Agents, Nonsteroidal Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2015