MedTrace Logo

Combined Foley Catheter Balloon and PGE2 Vaginal Ovule for Induction of Labor at Term: A Randomized Study

NCT02861079 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-02-01

No results posted yet for this study

Summary

This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 in induction of labor at term. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.

Conditions

  • Unfavorable Cervix, Cervical Ripening

Interventions

DEVICE

Foley catheter

An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.

DRUG

PGE2

10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal 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
2017-08-25
Primary Completion
2017-12-25
Completion
2017-12-25

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT02861079 on ClinicalTrials.gov