NCT03194126已完成不适用
Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年2月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- time taken between administration of 1st dose of drugs and delivery between the two strategies
研究概览
简要总结
Reducing the time patients spend in the labor and delivery room saves money and reduces patient discomfort as well and reducing complications. We will compare two methods for inducing cervical maturation in order to shorten the time taken between administration of drugs and delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The primary outcome will be evaluated by a blinded evaluator: the laminaria placement is performed by the on-call team at Day-1, whilst the delivery is performed by a different team at Day 0, with the laminaria removed in the morning.
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
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patients is at least 18 years old
- •Patient with a singleton pregnancy between 14 and 34 weeks gestation with an indication for medical termination due to maternal or fetal problem as validated by pluridisciplinary prenatal diagnosis center.
排除标准
- •The subject is participating in an interventional study or is in a period of exclusion determined by a previous study
- •The patient is under safeguard of justice
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •Patient has vaginismus
- •Patient has a cervix permitting artificial rupture of membrane
- •Patients taking one of the following treatments, contraindicated for mifepristone: ketoconazole, itraconazole, erythromycin, grapefruit juice, rifampicin, dexamethasone, St John's wort and certain anti-convulsants (phenytoin, phenobarbital, carbamazepine).
- •Patients contraindicated for oxytocine.
结局指标
主要结局
time taken between administration of 1st dose of drugs and delivery between the two strategies
时间窗: Up to 2 days
次要结局
- Patient anxiety between groups(Day 0 - 3 months)
- Evaluation of any post-traumatic stress between groups(3 months)
- Compare cervix length before administration of Misoprostol OR oxytocine between groups(Day 0)
- Compare time taken between Misoprostol OR oxytocine and delivery between groups(Day 0 - Day 2)
- Incidence of hemorrhage between groups(Day 0 - Day 2)
- Compare degree of dilation before administration of Misoprostol OR oxytocine between groups(Day 0)
- Patient satisfaction in peripartum between groups(Day 2)
- Compare pain experienced by patients between groups(Day 0 - Day 2)
- Rate of delivery between groups(>12 hours)
- Incidence of endometritis between groups(Day 0 - Day 2)
研究者
研究点 (4)
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