A Randomized Trial Comparing Oral Misoprostol Alone with Oral Misoprostol Followed by Oxytocin in Women Induced for Hypertension of Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 3
- 主要终点
- Caesarean birth
研究概览
简要总结
The primary objective of the trial is to assess the following: In women who have undergone cervical preparation with oral misoprostol as part of labour induction for hypertensive disease in India, is augmentation using oral misoprostol superior to the standard protocol of intravenous oxytocin?
详细描述
Every year approximately 30 000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion. However, some studies have shown that oral misoprostol can be continued into active labour. In the Cochrane review on labour induction, those whose augmentation was continued with misoprostol (M/M protocol) had 42% less CSs than those who changed to oxytocin (M/Ox protocol; 15% vs 26%). This misoprostol-only protocol would be simpler and probably more acceptable to women. However, these two protocols have never been directly compared. We propose a pragmatic, open-label, randomised trial to compare an M/M labour induction protocol with the standard M/Ox protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Ongoing pregnancies with a live fetus who require induction because of preeclampsia or hypertensionWomen will be included irrespective of whether an intrapartum caesarean birth on fetal grounds would be considered or not
- •Women age ≥18 years
- •Signed informed consent form
- •Undergone cervical ripening with misoprostol if cervix initially unfavourable
- •Decision to augment labour for inadequate uterine contractions despite ruptured membranes (either artificial or spontaneous as part of the induction process)s
排除标准
- •Women with previous caesarean births
- •Those unable to give informed consent
- •Cervical ripening with agents other than misoprostol (e.g. Foley catheter, prostaglandins)
- •Multiple pregnancy
- •History of allergy to misoprostol
- •Adequate uterine activity
- •Pre- induction Ruptured amniotic membranes
- •Frank chorioamnionitis (systemic illness with purulent vaginal discharge and uterine tenderness)
研究组 & 干预措施
Oxytocin infusion
- Oxytocin infusion will be given through an electronic infusion pump. One unit of oxytocin will be injected in 500 mL of Ringer's lactate, started at a rate of 2 mU/min, and increased every 30 min by 2 mU/min until there are three to four contractions every 10 min. The rate will be titrated to maintain that contraction frequency. The maximum dose will be 20mU/min as oxytocin summary product characteristics.
- The oxytocin group will not receive misoprostol after the membranes have ruptured.
干预措施: Oxytocin (Drug)
Oral misoprostol
- An initial dose of misoprostol 25mcg will be given orally after randomisation (this must be a minimum of 2 hours after the previous misoprostol dose).
- The next dose of oral misoprostol will be omitted if moderate or strong contractions are occurring at 3 in 10 minutes or more (i.e. 9 or more in the preceding 30 minutes)
- If contractions subsequently reduce to less than 3 in 10 (under 9 in 30 minutes), or become irregular or mild, then the oral misoprostol 25mcg can be restarted
- In the event of inadequate progress, clinicians will be advised to give further misoprostol if there are any concerns about contractions strength or frequency.
干预措施: Oral misoprostol (Drug)
结局指标
主要结局
Caesarean birth
时间窗: At delivery
Rate of caesarean birth in the treatment arm
次要结局
未报告次要终点