Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in Uniject®
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Mean change in Pre- and post-delivery Haemoglobin
研究概览
简要总结
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.
详细描述
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®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 1
600 mcg oral misoprostol
干预措施: Misoprostol (Drug)
Group 2
10 IU oxytocin in Uniject
干预措施: Oxytocin (Drug)
结局指标
主要结局
Mean change in Pre- and post-delivery Haemoglobin
时间窗: 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.
次要结局
- Clinical effectiveness(18 months)
- Programmatic feasibility(18 months)
- Cost-effectiveness(18 months)
- Safety(18 months)