Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in Uniject®
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Mean change in Pre- and post-delivery Haemoglobin
Study Overview
Brief Summary
This community-based cluster Randomised Control Trial will assess the feasibility, cost, risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as prophylaxis for postpartum hemorrhage (PPH) in community settings. The study will be conducted in Jamnagar district in Gujarat state in India. The hypothesis is that a program to deliver oral misoprostol and one to deliver oxytocin via Uniject® will both be effective in preventing PPH when introduced in community-based settings.
Detailed Description
Rationale for Research: Approximately 30% of maternal deaths in India are attributed to postpartum hemorrhage (PPH). The most common cause of PPH is uterine atony (failure of the uterus to contract properly after childbirth). Administration of an uterotonic drug as active management in the third stage of labor (AMTSL) can significantly reduce the rate of PPH. Oxytocin is considered the drug of choice for prevention of PPH. However, it is not always feasible to administer parenteral Oxytocin in resource-poor settings given the cold storage, sterile equipment, skilled personnel, and administration requirements. Recently, Oxytocin in Uniject®, a pre-filled, non-refillable easy to use device with a single measured dose has been found to be equally effective and safer and more convenient to use than traditional needle and syringe.
Misoprostol has been explored for preventing PPH in settings where parenteral uterotonics are not yet available or feasible to use. In 2007, the World Health Organisation in its guidelines on prevention of PPH endorsed the administration of oral Misoprostol for PPH prevention by unskilled providers "trained in its use in settings where Active management of the third stage of labor (AMTSL) is not practiced".
In spite of the evidence of clinical safety and efficacy of oral Misoprostol and/or Oxytocin in Uniject® as universal PPH prevention drugs, to date, there have been no studies comparing the programmatic effectiveness of either technology on a large scale or in nationwide PPH prevention programs. To address this gap, the investigators plan to conduct a large community-based trial in collaboration with the Aga Khan Health Services, India.
Study Objectives: The study will assess the feasibility, cost, risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as prophylaxis for PPH in community settings.
Study Design: The study is designed as a community-based cluster Randomised Control Trial. The study will enroll women delivering at Primary Health Centres (PHCs). Study centres will be assigned to one of the following: Group 1: 600 mcg oral Misoprostol, Group 2: 10 IU IM Oxytocin delivered by Uniject®.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant women planning vaginal delivery with a trained study provider at a PHC who are eligible to participate in research according to national guidelines and able to provide informed consent.
Exclusion Criteria
- •Women not delivering in study catchment area with a trained study provider will not be eligible to participate in the trial.
- •Women with known contraindications to prostaglandins, including misoprostol will also be excluded.
- •Women delivering in a facility that currently routinely administers prophylactic oxytocin to women in the third stage labor will also be excluded.
Arms & Interventions
Group 1
600 mcg oral misoprostol
Intervention: Misoprostol (Drug)
Group 2
10 IU oxytocin in Uniject
Intervention: Oxytocin (Drug)
Outcomes
Primary Outcomes
Mean change in Pre- and post-delivery Haemoglobin
Time Frame: 18 months
To establish the comparable effectiveness of two programmatic strategies, 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
- Clinical effectiveness(18 months)
- Programmatic feasibility(18 months)
- Cost-effectiveness(18 months)
- Safety(18 months)