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.

Study Overview

• Status: Completed
• Conditions: Vaginal Infection; Labor Induction; Effect Increased; Dinoprostone Vaginal Insert
• Intervention / Treatment: Procedure: vaginal lavage group; Procedure: Control Group

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Zeynep Kamil Maternity and Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vaginal lavage group; We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule	Procedure: vaginal lavage group; vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
Placebo Comparator: Control group; We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage.	Procedure: Control Group; vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Succesful cervical repining which allows succesful vaginal delivery	Cervical ripening is defined cervical Bishop score >5 the indication of unsuccessful induction	12 Months

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Investigators: Principal Investigator: İlter Yenidede, MD, Zeynep Kamil Maternity and Children Hospital; Principal Investigator: Çetin Kılıççı, Zeynep Kamil Maternity and Children Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): December 10, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: January 21, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2016-162

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No