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

NCT ID: NCT03050684

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2017-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Labor Induction Dinoprostone Vaginal Insert Vaginal Infection Effect Increased

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Study
Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vaginal lavage group

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

Group Type ACTIVE_COMPARATOR

vaginal lavage group

Intervention Type PROCEDURE

vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.

Control group

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

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type PROCEDURE

vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.

Interventions

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vaginal lavage group

vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.

Intervention Type PROCEDURE

Control Group

vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Çiğdem Yayla Abide

Ob&Gyn Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İlter Yenidede, MD

Role: PRINCIPAL_INVESTIGATOR

Zeynep Kamil Maternity and Children Hospital

Çetin Kılıççı

Role: PRINCIPAL_INVESTIGATOR

Zeynep Kamil Maternity and Children Hospital

Locations

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Zeynep Kamil Maternity and Children Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2016-162

Identifier Type: -

Identifier Source: org_study_id