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

Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal

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

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Device: UnijectTM; Drug: Misoprostol

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 Type: Interventional
• Enrollment (Actual): 1365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Senegal
  • Thiadiaye and Kolda
    • Thiadiay and Kolda, Thiadiaye and Kolda, Senegal
      • Health huts in the district of Thiadiaye and Kolda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in hemoglobin	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	during 3rd trimester and 1-3 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correct timing of drug administration	administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta	collected immediately following birth, verified 1-3 days postpartum
change in hemoglobin ≥ 2 g/dL		during third trimester and 1-3 days postpartum
acceptability	acceptability according to woman of study medication, care received, side effects experienced	1-3 days postpartum
Occurrence and management of side effects	nausea, vomiting, diarrhea, shivering, fever	1 hour postpartum
additional interventions	use of additional uterotonics, manual removal of placental fragments, etc	during birth
referrals	referral requested, transfers carried out, reasons for incomplete referrals/transfers	0-3 days postpartum

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: ChildFund International

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: oxytocin; prevention; postpartum hemorrhage; misoprostol; Uniject
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 2.4.9