Does Vaginal Washing Before Inserting Dinoprostone Affect the Success Rate of the Labour Induction?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Succesful cervical repining which allows succesful vaginal delivery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
vaginal lavage group
We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule
干预措施: vaginal lavage group (Procedure)
Control group
We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage.
干预措施: Control Group (Procedure)
结局指标
主要结局
Succesful cervical repining which allows succesful vaginal delivery
时间窗: 12 Months
Cervical ripening is defined cervical Bishop score \>5 the indication of unsuccessful induction
次要结局
未报告次要终点
研究者
Çiğdem Yayla Abide
Ob&Gyn Specialist
Zeynep Kamil Maternity and Pediatric Research and Training Hospital