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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. Occurrence and management of side effects [ Time Frame: 1 hour postpartum ]
   nausea, vomiting, diarrhea, shivering, fever
2. 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
3. change in hemoglobin ≥ 2 g/dL [ Time Frame: during third trimester and 1-3 days postpartum ]
4. additional interventions [ Time Frame: during birth ]
   use of additional uterotonics, manual removal of placental fragments, etc
5. referrals [ Time Frame: 0-3 days postpartum ]
   referral requested, transfers carried out, reasons for incomplete referrals/transfers
6. acceptability [ Time Frame: 1-3 days postpartum ]
   acceptability according to woman of study medication, care received, side effects experienced

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Diop A, Daff B, Sow M, Blum J, Diagne M, Sloan NL, Winikoff B. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial. Lancet Glob Health. 2016 Jan;4(1):e37-44. doi: 10.1016/S2214-109X(15)00219-3.

Responsible Party:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT01713153 History of Changes
Other Study ID Numbers:	2.4.9
First Posted:	October 24, 2012
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