Clinical trial NCT03050684: Does Vaginal Washing Affect the Success Rate of the Labour Induction?
Official title: Does Vaginal Washing Before Inserting Dinoprostone Affect the Success Rate of the Labour Induction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Induction
Dinoprostone Vaginal Insert
Vaginal Infection
Effect Increased
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Succesful cervical repining which allows succesful vaginal delivery
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Maternity and Children Hospital
Study officials:
affiliation: Zeynep Kamil Maternity and Children Hospital
name: İlter Yenidede, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zeynep Kamil Maternity and Children Hospital
name: Çetin Kılıççı
role: PRINCIPAL_INVESTIGATOR
References: