Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal
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| ClinicalTrials.gov Identifier: NCT01713153 |
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Recruitment Status :
Completed
First Posted : October 24, 2012
Last Update Posted : February 25, 2016
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Sponsor:
Gynuity Health Projects
Collaborator:
ChildFund International
Information provided by (Responsible Party):
Gynuity Health Projects
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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: Misoprostol Device: UnijectTM | Not Applicable |
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 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 |
| Actual Primary Completion Date : | January 2014 |
| Actual Study Completion Date : | January 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Misoprostol
600 mcg oral misoprostol administered during the third stage of labor
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Drug: Misoprostol
600 mcg misoprostol oral
Other Names:
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Experimental: UnijectTM
10 IU oxytocin delivered IM with UnijectTM during he third stage of labor
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Device: UnijectTM
10 IU oxytocin delivered intramuscularly with UnijectTM |
Primary Outcome Measures :
- 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 :
- Occurrence and management of side effects [ Time Frame: 1 hour postpartum ]nausea, vomiting, diarrhea, shivering, fever
- 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
- change in hemoglobin ≥ 2 g/dL [ Time Frame: during third trimester and 1-3 days postpartum ]
- additional interventions [ Time Frame: during birth ]use of additional uterotonics, manual removal of placental fragments, etc
- referrals [ Time Frame: 0-3 days postpartum ]referral requested, transfers carried out, reasons for incomplete referrals/transfers
- acceptability [ Time Frame: 1-3 days postpartum ]acceptability according to woman of study medication, care received, side effects experienced
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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
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
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:
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postpartum hemorrhage prevention misoprostol Uniject oxytocin |
Additional relevant MeSH terms:
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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 |