NCT02861079

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_2

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

August 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

August 25, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

August 1, 2016

Last Update Submit

January 31, 2018

Conditions

Unfavorable Cervix, Cervical Ripening

Outcome Measures

Primary Outcomes (1)

  • induction-to- delivery time

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

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

Secondary Outcomes (1)

  • induction-to-active phase of labor time

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

Study Arms (2)

Propess with Foley balloon catheter

EXPERIMENTAL

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

Device: Foley catheterDrug: PGE2

Propess vaginal ovule

ACTIVE COMPARATOR

10 mg PGE2 vaginal ovule will be inserted to the posterior fornix

Drug: PGE2

Interventions

Foley catheterDEVICE

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

Propess with Foley balloon catheter
PGE2DRUG

10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.

Also known as: propess
Propess vaginal ovulePropess with Foley balloon catheter

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
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,
  • a category II or III fetal heart rate pattern,
  • anomalous fetus,
  • fetal demise
  • women with immediate delivery indications -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Du C, Liu Y, Liu Y, Ding H, Zhang R, Tan J. Double-balloon catheter vs. dinoprostone vaginal insert for induction of labor with an unfavorable cervix. Arch Gynecol Obstet. 2015 Jun;291(6):1221-7. doi: 10.1007/s00404-014-3547-3. Epub 2014 Nov 19.

    PMID: 25408273RESULT

  • Dalui R, Suri V, Ray P, Gupta I. Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. Acta Obstet Gynecol Scand. 2005 Apr;84(4):362-7. doi: 10.1111/j.0001-6349.2005.00662.x.

    PMID: 15762966RESULT

  • 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

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

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
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 10, 2016

Study Start

August 25, 2017

Primary Completion

December 25, 2017

Study Completion

December 25, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

TU(1)