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

Not Applicable

Completed

• Conditions: Vaginal Infection; Labor Induction; Dinoprostone Vaginal Insert; Effect Increased
• Interventions: Procedure: Control Group; Procedure: vaginal lavage group

• Registration Number: NCT03050684
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-01-21
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-13
• Study Start: 2017-02-20
• Primary Completion: 2017-12-10
• Study Completion: 2017-12-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control Group	We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage.
vaginal lavage group	vaginal lavage group	We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule

Primary Outcome Measures

Name	Time	Method
Succesful cervical repining which allows succesful vaginal delivery	12 Months	Cervical ripening is defined cervical Bishop score \>5 the indication of unsuccessful induction

Trial Locations

Locations (1)

Zeynep Kamil Maternity and Children Hospital; 🇹🇷 Istanbul, Turkey