Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction (COLIGROW)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 10
- 主要终点
- Vaginal delivery; [yes/no]
研究概览
简要总结
The goal of this clinical trial is to compare how two methods for cervical ripening work in a population of singleton pregnancies with late-onset fetal growth restriction (FGR) at term.
The main question it aims to answer is whether Cook´s balloon (a mechanical method) is superior to vaginal dinoprostone (a pharmacological method) in achieving a vaginal delivery.
Participants will be randomized to receive Cook´s balloon (experimental group) or vaginal dinoprostone (control group) for cervical ripening.
Researchers will compare both groups to see if Cook´s balloon is associated with a higher rate of vaginal delivery than vaginal dinoprostone. Neonatal outcomes (including neonatal acidosis, the MAIN morbidity score, and NICU admission) will be assessed as secondary, descriptive endpoints.
详细描述
Late-onset fetal growth restriction (FGR) represents the most common subtype of FGR (70-80%). The greatest risk for these fetuses appears once term pregnancy is reached, when stressful situations are added to their status of relative hypoxia, such as the appearance of contractions and funicular compression. Thus, it has been shown that from week 37-38 the risk of intrauterine mortality increases and there is a general consensus not to prolong these pregnancies beyond this period. In this situation, induction of labor is usually preferred over elective caesarean delivery. However, these fetuses have an increased risk of cesarean section for suspected fetal distress.
Mechanical methods for cervical ripening are associated with less uterine stimulation with a lower rate of tachysystole than prostaglandins. Therefore, these methods have been proposed as the optimal approach for late-onset FGR, since they could reduce the rate of cesarean sections for suspected fetal distress. However, there is no published randomized controlled trials on the use of different methods of cervical ripening for labor induction in late-onset FGR.
Thus, the investigators postulate that, in late-onset FGR, cervical ripening with a mechanical method (Cook´s balloon) achieves a higher percentage of vaginal deliveries than a pharmacological method (vaginal dinoprostone), being safe for both the mother and the newborn.
The main aim of this study is to evaluate whether cervical ripening with Cook balloon for labor induction at term gestation of singleton pregnancies with late-onset FGR achieves a higher rate of vaginal delivery compared to the use of vaginal dinoprostone. Neonatal safety outcomes (neonatal acidosis, the MAIN morbidity score, and NICU admission) will be analyzed as secondary endpoints, in a descriptive manner.
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
盲法说明
No masking
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
- •Singleton pregnancy
- •Age ≥ 18 years
- •Gestational age (GA) dated by first trimester ultrasound ≥ 37+0 weeks
- •Cephalic presentation
- •Stage I fetal growth restriction, defined as the presence of at least one of these two criteria:
- •Estimated fetal weight (EFW) < 3rd percentile
- •EFW < 10th percentile and at least one of the following: 2.1) Umbilical artery pulsatility index > 95th percentile or 2.2) Cerebral-placental index < 5th percentile
- •Bishop score < 7
- •Intact fetal membranes
- •No previous caesarean section
- •No contraindications for vaginal delivery or labor induction.
排除标准
- •Major fetal malformation
- •Fetal genetic abnormality
- •Fetal congenital infection
结局指标
主要结局
Vaginal delivery; [yes/no]
Vaginal delivery; [yes/no]
Rate of vaginal delivery
时间窗: 2 days (from admission to delivery)
To assess whether cervical ripening with a Cook balloon for induction of labor of term pregnancies with FGR increases the rates of vaginal delivery with respect to the use of vaginal dinoprostone.
次要结局
- Rate of cesarean sections due to suspected fetal distress(2 days (from admission to delivery))
- Neonatal morbidity(From delivery to discharge of the newborn (up to 1 month))
- Induction-to-delivery interval(2 days (from admission to delivery))
研究者
Ignacio Herraiz
Adjunct professor
Hospital Universitario 12 de Octubre