Does Vaginal Washing Affect the Success Rate of the Labour Induction?
Does Vaginal Washing Before Inserting Dinoprostone Affect the Success Rate of the Labour Induction?
Investigators will use dinoprostone(Propess TM) for cervix ripening and labor induction in term pregnant women.Vaginal pH base is achieved with the effect of hormones in pregnancy and associated with this, vaginal infections rates increase. With the vaginal application of Propess, the preparate remains in the vagina for a long time, with controlled release,creating a film layer against bacteria and especially fungal infections and it was thought that this could be a reason for unsuccessful birth induction by preventing release of this ovule.
The aim of this study is to observe whether or not the rate of caesareans with the indication of unsuccessful induction was reduced in patients by reducing the density of vaginal bacteria and fungi with vaginal lavage and thereby increasing the effect of the drug and decreasing the rate of unsuccessful inductions.
研究概览
详细说明
The study will include patients meeting the study criteria monitored in the delivery .
Verbal and written informed consent will be obtained from all patients before starting the study. The patients will be randomised to 2 groups. In one group, vaginal lavage (the vagina will first be washed with saline in a 20cc injector) will be applied then Propess will be used and in the other group Propess will be used without any lavage.
It is planned to include 70 patients in each group.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Istanbul、火鸡
- Zeynep Kamil Maternity and Children Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with singleton pregnancies
- Term gestational week (defined as>37 weeks),
- Fetal cephalic presentation
- Participiants with with intact amniotic membrane
- Reactive fetal heart rate
- Cervical Modified Bishop's score <5
Exclusion Criteria:
- Patients with with multipl pregnancies
- Participiants with malpresentation anomalies
- Participiants with nonreassurring fetal heart rate
- Participiants with more than three contractions in 10 minutes
- Participiants with contrandications for using prostaglandins
- Participiants with fetal anomaly
- Participiants with fetal demise
- Participiants with emercency delivery indications,
- Participiants with previous cesarean delivery or have other uterine surgery
- Participiants with cephalopelvic disproportion
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：vaginal lavage group
We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule
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vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
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安慰剂比较：Control group
We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage.
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vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Succesful cervical repining which allows succesful vaginal delivery
大体时间：12 Months
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Cervical ripening is defined cervical Bishop score >5 the indication of unsuccessful induction
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12 Months
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合作者和调查者
调查人员
- 首席研究员：İlter Yenidede, MD、Zeynep Kamil Maternity and Children Hospital
- 首席研究员：Çetin Kılıççı、Zeynep Kamil Maternity and Children Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2016-162
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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