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Completed

NCT Number: NCT03050684

Does Vaginal Washing 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.

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Key information

Conditions

Labor Induction Dinoprostone Vaginal Insert Effect Increased Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginal Infection Vaginitis

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Maternity and Children Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaginal lavage group

Procedure

vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.

Control Group

Procedure

vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.

Primary outcomes

  1. Succesful cervical repining which allows succesful vaginal delivery

    Time frame: 12 Months

    Cervical ripening is defined cervical Bishop score >5 the indication of unsuccessful induction

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2017
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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