NCT03629548

Brief Summary

This study evaluates the intervention for induction of labor with low bishop scores . One group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at term.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

March 27, 2018

Last Update Submit

February 1, 2021

Conditions

Induced Vaginal Delivery

Keywords

dinoprostoneearly amniotomylabor inductionfoley bulb

Outcome Measures

Primary Outcomes (1)

  • induction-to- delivery time

    the length of time between the beginning of induction and the end of labor

    from the beginning of induction until the labor

Secondary Outcomes (1)

  • induction-to-active phase of labor time

    from the beginning of induction until the labor

Study Arms (2)

early amniotomy plus dinoprostone

ACTIVE COMPARATOR

10 mg dinoprostone vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.

Procedure: early amniotomy

foley balloon catheter plus dinoprostone

EXPERIMENTAL

an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg dinoprostone vaginal ovul will be inserted to the posterior fornix

Device: foley catheter balloon placement

Interventions

early amniotomyPROCEDURE

10 mg PGE2 vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.

early amniotomy plus dinoprostone
foley catheter balloon placementDEVICE

an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix

Also known as: mechanic and medical method
foley balloon catheter plus dinoprostone

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsterm pregnancies
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancy,
  • gestational age ≥37 weeks,
  • intact membranes,
  • cephalic presentation,
  • bishop score ≤5,
  • had obstetrical indications for induction of labor,
  • had less than three uterine contractions in every 10 minutes.

You may not qualify if:

  • Patients who had contraindications for vaginal delivery,
  • previous uterine surgery,
  • fetal malpresentation,
  • multifetal pregnancy,
  • more than three contractions in 10 minutes,
  • contraindications to prostaglandins,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Education and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

Study Officials

  • ahmet eser, M.D.

    Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 27, 2018

First Posted

August 14, 2018

Study Start

August 15, 2018

Primary Completion

September 15, 2019

Study Completion

October 1, 2019

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

TU(1)