The Effectiveness and Safety of Double-balloon Versus Vaginal Prostaglandin for Cervical Ripening in Women With Low-risk Pregnancies: A Randomized Controlled Trial (DOBA-PRO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Number of participants delivered vaginally
研究概览
简要总结
To compare the effectiveness and safety of double balloon catheter and vaginal insert Prostaglandin E2 in cervical ripening prior to Induction of Labor in low-risk women from 39+0 to 40+6 weeks of gestation.
详细描述
Induction of labor (IOL) is a technique to establish vaginal delivery when the risks for continuing the pregnancy for mother or baby are higher than the risks of delivery. In case the cervix is unripe, cervical ripening before the onset of labor is needed. The two main mechanisms of cervical ripening can be categorized as mechanical or pharmacological.
A Cochrane systematic review and other recent meta-analysis have shown that cervical ripening with a balloon is probably as effective as induction of labor with vaginal Prostaglandin E2. However, this conclusion is based on low to moderate quality evidence. Only a limited number of randomized clinical trials (RCTs) have been conducted. Many of those suffering from small sample sizes and different study subjects, i.e. high-risk subjects only, and mixed population.
In current practice, induction of labor is not only used in high-risk patients with clear indications for pregnancy termination. The ARRIVE trial has shown a significant benefit of labor induction over expectant management among the low-risk population. Based on this evidence, the American College of Obstetricians and Gynecologists (ACOG) has suggested: "It's time to induce of labor at 39th week of gestation". Since then, there is a trend in favoring elective induction before the due date over expectant management. Besides, more and more pregnant women want to shorten the duration of pregnancy or to time the birth of the baby due to the convenience of the mother and/or healthcare workers.
This makes the optimal method of Induction of Labor in terms of effectiveness and safety for both mothers and their babies even more important. In this study, the investigators will compare the effectiveness and safety of double-balloon catheter and Prostaglandin E2 for elective labor induction in low-risk pregnancies.
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
- •Maternal age ≥ 18
- •Singleton pregnancy. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks gestational age.
- •Gestational age at randomization from at 39+0 to 40+6 weeks of gestation.
- •Cephalic presentation
- •Intact membrane
- •Unfavourable cervix (Bishop<6)
- •Informed consent
排除标准
- •Maternal medical illness associated with increased risk of adverse pregnancy outcome (any diabetes mellitus, any hypertensive disorders, cardiac diseases, renal insufficiency, systemic lupus erythematosus, mental disorders, HIV positive, use of heparin or low-molecular weight heparin during the current pregnancy etc.)
- •Abnormal placenta: Active vaginal bleeding greater than bloody show or placenta previa, accreta or vasa previa
- •Abnormal amniotic fluid volume:
- •Oligohydramnios (MVP < 2cm)
- •Polyhydramnios (MVP > 10cm)
- •Abnormal fetus
- •Fetal demise or known major fetal anomalies
- •Fetal growth restriction (FGR) (EFW < 3% or < 10% and abnormal Doppler)
- •Non-reassuring fetal status (no fetal movements, abnormal fetal heart rate at auscultation)
- •Previous C-section
- •Planned for C-section or contra-indication to labour
- •Cerclage or use of pessary in current pregnancy
- •Refusal of blood product.
- •Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality
研究组 & 干预措施
Double-balloon catheter group
Sweeping the membranes by UTAH CVX-RIPE® (Utah Medical Products, Inc, 7043 South 300 West, Midvale, Utah 84047 USA).
干预措施: Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening (Device)
Vaginal insertion Prostaglandin E2 group
Propess® 10mg Vaginal delivery system (Ferring Controlled Therapeutics Ltd., 1 Redwood Place, Peel Park Campus, East Kilbride, Glasgow, G74 5PB, UK) is a vaginal insert containing 10mg of dinoprostone in a timed-release formulation (the medication is released at 0.3 mg/hour).
干预措施: Dinoprostone 10mg (Propess) (Drug)
结局指标
主要结局
Number of participants delivered vaginally
时间窗: From randomization until delivery, assessed up to 3 days after randomization
Number of participants delivered vaginally
次要结局
- Number of participants with Side - effect of induction's method(From induction until delivery, assessed up to 3 days after induction)
- Number of participants having oxytocin augmentation(From induction until delivery, assessed up to 3 days after induction)
- Number of participants with uterine tachysystole(From induction until delivery, assessed up to 3 days after induction)
- Time from induction of labor to delivery(From induction until delivery, assessed up to 3 days after induction)
- Number of participants delivered vaginally within 24 hours(Within 24 hours from labor induction)
- Number of participants with post-partum haemorrhage(Within 24 hours from delivery)
- Number of participants having uterine atony(From delivery until maternal hospital discharge, assessed up to 28 days after delivery)
- Number of participants having maternal post-partum blood transfusion(From delivery until maternal hospital discharge, assessed up to 28 days after delivery)
- Number of participants with hypertension complications(From randomization until maternal hospital discharge, assessed up to 28 days after randomization)
- Number of participants with uterine dehiscence or rupture(From delivery until maternal hospital discharge, assessed up to 28 days after delivery)
- Number of participants with maternal infection(From induction until maternal hospital discharge, assessed up to 28 days after induction)
- Number of participants with hysterectomy(From delivery until maternal hospital discharge, assessed up to 28 days after delivery)
- Number of participants with damage to internal organs(From delivery until maternal hospital discharge, assessed up to 28 days after delivery)
- Number of participants with other post-partum complications(From randomization until maternal hospital discharge, assessed up to 28 days after randomization)
- Number of participants admitted to intensive care unit(From randomization until maternal hospital discharge, assessed up to 28 days after randomization)
- Number of maternal death among participants(From randomization until maternal hospital discharge, assessed up to 28 days after randomization)
- Number of participants referred to other hospital due to severe morbidities(From randomization until maternal hospital referral, assessed up to 28 days after randomization)
- Maternal length of stay(From admission until maternal hospital discharge, assessed up to 28 days after admission)
- Number of Infants with Apgar Score ≤7 at 1 and 5 minutes(Assessed at 1 and 5 minute after birth)
- Number of neonates admitted to the Neonatal Intensive Care Unit or Intermediate care unit(From delivery until admission to Neonatal Intensive Care Unit or Intermediate care unit, assessed up to 7 days after delivery)
- Number of participants using more than one induction agent required(From induction until delivery, assessed up to 3 days after induction)
- Psychometric aspects(At admission (version A) and before maternal hospital discharge (version B), assessed up to 28 days after admission)
- Apgar scores at 1 and 5 minute(Assessed at 1 and 5 minute after birth)
- Reason for Neonatal Intensive Care Unit admission(From delivery until Neonatal Intensive Care Unit admission, assessed up to 28 days after delivery)
- Length of stay at the Neonatal Intensive Care Unit or Intermediate care unit(From admission to Neonatal Intensive Care Unit/ Intermediate care unit until neonatal discharge or hospital referral, assessed up to 28 days after Neonatal Intensive Care Unit admission)
- Number of neonates with birth trauma(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonates with hypoglycemia(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonates with jaundice and hyperbilirubinemia(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonates with Hypoxic ischemic encephalopathy or need for therapeutic hypothermia(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonates with meconium aspiration syndrome(From delivery until neonatal hospital discharge, assessed up to 07 days after delivery)
- Number of neonates in need for respiratory supports(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonates with neonatal infection(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonates with neonatal seizures(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonates with intracranial hemorrhage(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonates need blood transfusion(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonatal deaths(From delivery until neonatal hospital discharge, assessed up to 28 days after delivery)
- Number of neonates referred to other hospital for severe morbidities(From delivery until neonatal hospital referral, assessed up to 28 days after delivery)