NCT03050684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2017

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

January 21, 2017

Last Update Submit

January 29, 2018

Conditions

Labor InductionDinoprostone Vaginal InsertVaginal InfectionEffect Increased

Outcome Measures

Primary Outcomes (1)

  • Succesful cervical repining which allows succesful vaginal delivery

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

    12 Months

Study Arms (2)

vaginal lavage group

ACTIVE COMPARATOR

We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule

Procedure: vaginal lavage group

Control group

PLACEBO COMPARATOR

We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage.

Procedure: Control Group

Interventions

vaginal lavage groupPROCEDURE

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

vaginal lavage group
Control GroupPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Maternity and Children Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vaginitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • İlter Yenidede, MD

    Zeynep Kamil Maternity and Children Hospital

    PRINCIPAL INVESTIGATOR

  • Çetin Kılıççı

    Zeynep Kamil Maternity and Children Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ob&Gyn Specialist

Study Record Dates

First Submitted

January 21, 2017

First Posted

February 13, 2017

Study Start

February 20, 2017

Primary Completion

December 10, 2017

Study Completion

December 20, 2017

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

TU(1)