INVERT: IV Nitroglycerin for Versions Trial - a Randomized Placebo-controlled Trial in Nulliparous Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure
研究概览
简要总结
Breech presentations (where a baby presents with feet or bottom down) have an increased risk of perinatal and neonatal complications, and are usually delivered by cesarean section. As an alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the baby so that it is head down: this manoeuvre is called an external cephalic version (ECV).
Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in women who have not previously been pregnant (nulliparous women) than in women who have been pregnant more than once (multiparous women), and so we have planned two trials.
This study is designed to answer the following questions for nulliparous women:
Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates? Will an increase in ECV success result in a decreased cesarean section rate?
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •any non-cephalic presentation
- •singleton pregnancy
- •>/= 37 weeks gestational age
- •normal amniotic fluid volume
- •reassuring fetal heart rate
排除标准
- •ruptured membranes
- •history of third trimester bleeding
- •any pre-existing uterine scar
- •pregnancy induced hypertension and gestational diabetes
- •oligohydramnios and polyhydramnios
- •intrauterine growth restriction or macrosomia
- •hypotension or any serious medical illness
- •inability to comprehend the consent form
研究组 & 干预措施
1
Treatment solution consisted of 100 micrograms/mL of nitroglycerin. After an initial 1ml dose, further doses could be given in 1-3mL increments until uterine relaxation was achieved, or up to a recommended maximum of 10mL
干预措施: IV Nitroglycerin (Drug)
2
Placebo solution was saline. After an initial 1ml dose, further doses could be given in 1-3mL increments until uterine relaxation was achieved, or up to a recommended maximum of 10mL
干预措施: Normal saline (Drug)
结局指标
主要结局
Success of ECV (ie fetus turned from Breech to cephalic) at the end of ECV procedure
时间窗: Recorded at finish of ECV attempt
次要结局
- Success of ECV (ie fetus in cephalic presentation) at time of delivery(Recorded at time of birth)
- Mode of delivery(Recorded at time of birth)
- Maternal side effects and adverse events(Recorded until date of birth (up to 3 weeks following ECV))