Does Vaginal Washing Affect the Success Rate of the Labour Induction?

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status: Completed

Conditions: Labor Induction; Vaginal Infection; Dinoprostone Vaginal Insert; Effect Increased

Treatments: Procedure: Control Group; Procedure: vaginal lavage group

Study type: Interventional

Funder types: Other

Identifiers

NCT03050684

2016-162

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

vaginal lavage group

Active Comparator group

Description:

We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule

Treatment:

Procedure: vaginal lavage group

Control group

Placebo Comparator group

Description:

We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage.

Treatment:

Procedure: Control Group