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Completed

NCT Number: NCT01713153

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

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Health huts in the district of Thiadiaye and Kolda

Thiadiay and Kolda, Thiadiaye and Kolda, Senegal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

600 mcg misoprostol oral

Other names: Cytotec, Misoclear

UnijectTM

Device

10 IU oxytocin delivered intramuscularly with UnijectTM

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • ChildFund International

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2012
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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