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Completed

NCT Number: NCT02226588

Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt

The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.

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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

Phase 4

Primary location

Primary Health Care Units, Damanhur, El Beheira, Egypt

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Willing and able to give informed consent
  • Vaginal delivery
  • Agrees to participate in follow-up interview
  • Agrees to have pre- and post-hemoglobin taken
  • Delivery at woman's home or at the primary health unit (PHU)

Exclusion criteria

  • Too advanced into active labor to provide consent
  • Known allergy to misoprostol and/or other prostaglandin
  • Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester

Treatment and study plan

Misoprostol

Drug

Primary outcomes

  1. Mean drop in pre- to post-delivery hemoglobin level

    Time frame: Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.

    Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.

Secondary outcomes

  1. Proportion of women transferred to higher level care

    Time frame: Following delivery to postpartum visit (2 to 4 days after delivery)

    The proportion of women transferred to higher level care will be assessed. Includes the condition of woman at time of transfer and arrival at transfer facility.

  2. Proportion of women diagnosed with PPH

    Time frame: After delivery of the baby up to 24 hours postpartum

    PPH will be diagnosed using the standard practices of PHU staff

  3. Proportion of women receiving additional interventions for PPH

    Time frame: Following delivery to postpartum visit (2 to 4 days after delivery)

    An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding.

  4. Proportion of women who experience side effects

    Time frame: From time of delivery to 2 hours postpartum

    Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed

  5. Proportion of women who find the intervention acceptable

    Time frame: Measured at postpartum visit (2 to 4 days after delivery)

    Acceptability will be assessed in an exit interview with women - women will be asked if they are willing to take misoprostol in future deliveries and about the preferences what method they would prefer (primary or secondary prevention) in future deliveries.

  6. Proportion of women who receive intervention per protocol

    Time frame: within 2 hours of delivery

    To assess feasibility, we will document the proportion of women for whom the intervention arm protocol is correctly followed (including correct timing of drug administration, when necessary).

  7. Proportion of women experiencing a serious adverse event

    Time frame: Within 2 to 4 days after delivery

    Serious adverse events include hysterectomy, blood transfusion, maternal death

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • El Galaa Teaching Hospital
  • Ministry of Health and Population, Egypt
  • University of Alexandria

Registry information

Official study title

Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in El Beheira Governorate, Egypt

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 27, 2014
Registry last updated
Feb 15, 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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