Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01713153 |
Recruitment Status
:
Completed
First Posted
: October 24, 2012
Last Update Posted
: February 25, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postpartum Hemorrhage | Drug: Misoprostol Device: UnijectTM | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
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
|
- 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
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Senegal | |
Health huts in the district of Thiadiaye and Kolda | |
Thiadiay and Kolda, Thiadiaye and Kolda, Senegal |
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:
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 Abortifacient Agents, Nonsteroidal Abortifacient Agents Anti-Ulcer Agents Gastrointestinal Agents |