Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 160
- 试验地点
- 7
- 主要终点
- Rate of deliveries vaginally
研究概览
简要总结
According perinatal surveys, induction of labor is performed at more than 20% of pregnant women.
According to a survey on the trigger practices in France, prostaglandins are widely used to initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®).
The overall work-up rate due to the use of a single Propess® is 74.6% with 80% of vaginal deliveries.
Currently, 25.4% of patients who was not put in work after 24 hours are triggered by oxytocin (Syntocinon®) or directly caesarean. The initial installation of intravaginal dinoprostone limits the use of oxytocin (Syntocinon®) or in lower doses.
Using a second Propess® is carried out in several maternity hospitals, as reported by the survey on the cervical ripening practices in France. This second administration could be the solution to reduce the rate of caesarean in France which amounted to 20.8%.
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
- •Patient who is >=18 years.
- •Term pregnancy > 37 weeks
- •Induction of labor in progress, medically indicated
- •Patients who have had the establishment of a first Propess®, within 24 to 36 hours (before signing the consent)
- •Cephalic presentation
- •Unfavorable cervical conditions (Bishop score <6) 1 hour prior to inclusion
- •Intact Membranes
- •Affiliated with a social security system
- •Having signed the consent form.
排除标准
- •Multiple pregnancy
- •Uterus scar
- •Contraindications to epidural anesthesia
- •Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins Adverse effects appeared in the first Propess®: anaphylactic shock, disseminated intravascular coagulation (DIC).
- •Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
- •Contraindications to vaginal delivery (placenta previa, previa obstacle ...)
- •Premature Rupture of Membranes (PROM)
- •Intra Uterine Growth Retardation (IUGR) <3rd percentile
- •Macrosomia> 97th percentile
- •Severe Impaired fetal heart rate
- •In Utero Fetal Death (IUFD)
- •Medical Termination of pregnancy or lethal fetal pathology
- •Patient under guardianship or trusteeship safeguard justice
研究组 & 干预措施
Dinoprostone
In case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10 mg), patients receive a second Propess®, followed by Oxytocin 5U.I/ml (Syntocinon®) (if necessary) and epidural analgesia if desired by the patient.
干预措施: Dinoprostone (Drug)
Oxytocine
In case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10mg), patients receive directly Oxytocin 5U.I/ml (Syntocinon®) and epidural analgesia if desired by the patient.
干预措施: Oxytocine (Drug)
结局指标
主要结局
Rate of deliveries vaginally
时间窗: At delivery
The rate of births vaginally in each arm
次要结局
- Apgar score(3 Min, 5 Min and 10 Min)
- Hospital stay of mother(10 Days)
- Proportion of instrumental delivery(At delivery)
- Transfer in Intensive Care Unit(10 Days)
- Maternal death(10 Days)
- Proportion of complications of delivery and various care.(Day 1)
- Caesarean indications(At delivery)
- Fetal / neonatal death(At the birth)
- Failure of induction of labor(At delivery)
- Time of work(delivery time)
- Proportion of complete uterine rupture(At delivery)
- Proportion of transfer neonatal or newborn intensive care unit(At the birth)
- Assessment of fetal acidosis by measuring of pH, lactates and base excess(At the birth)
- Visual estimation of presence of amniotic fluid meconium(At the birth)