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

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ClinicalTrials.gov Identifier: NCT03050684
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Çiğdem Yayla Abide, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

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.


Condition or disease Intervention/treatment Phase
Labor Induction Dinoprostone Vaginal Insert Vaginal Infection Effect Increased Procedure: vaginal lavage group Procedure: Control Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Does Vaginal Washing Before Inserting Dinoprostone Affect the Success Rate of the Labour Induction?
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : December 10, 2017
Actual Study Completion Date : December 20, 2017

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050684


Locations
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Turkey
Zeynep Kamil Maternity and Children Hospital
Istanbul, Turkey
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Investigators
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Principal Investigator: İlter Yenidede, MD Zeynep Kamil Maternity and Children Hospital
Principal Investigator: Çetin Kılıççı Zeynep Kamil Maternity and Children Hospital
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Responsible Party: Çiğdem Yayla Abide, Ob&Gyn Specialist, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier: NCT03050684    
Other Study ID Numbers: 2016-162
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No