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

Vaginal Infection Clinical Trial

Official title:

Does Vaginal Washing Before Inserting Dinoprostone Affect the Success Rate of the Labour Induction?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050684
• Other study ID #: 2016-162
• Status: Completed
• Phase: N/A
• First received: January 21, 2017
• Last updated: January 29, 2018
• Start date: February 20, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2018
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 20, 2017
• Est. primary completion date: December 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dinoprostone Vaginal Insert
• Effect Increased
• Labor Induction
• Vaginal Infection

Intervention

Procedure:
• vaginal lavage group
vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
• Control Group
vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Maternity and Children Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Succesful cervical repining which allows succesful vaginal delivery	Cervical ripening is defined cervical Bishop score >5 the indication of unsuccessful induction	12 Months