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Comparing Foley Catheter Balloon With Early Amniotomy for Induction of Labor at Term

NCT03629548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2021-02-04

No results posted yet for this study

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.

Conditions

  • Induced Vaginal Delivery

Interventions

PROCEDURE

early amniotomy

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.

DEVICE

foley catheter balloon placement

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

Sponsors & Collaborators

  • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    lead OTHER

Principal Investigators

  • ahmet eser, M.D. · Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2019-09-15
Completion
2019-10-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629548 on ClinicalTrials.gov