NCT03050684

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?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	vaginal lavage group	vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
PROCEDURE	Control Group	vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.

Timeline

• Start date: 2017-02-20
• Primary completion: 2017-12-10
• Completion: 2017-12-20
• First posted: 2017-02-13
• Last updated: 2018-01-31

Locations

1 site across 1 country: Turkey (Türkiye)