NCT02486679

Brief Summary

A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

June 22, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

June 22, 2015

Last Update Submit

April 28, 2016

Conditions

Labor, Induced

Outcome Measures

Primary Outcomes (1)

  • Time to active labor

    Hours from foley cather placement or first PGE2 tablet placment to active labor, defined as cervical dilitation \>4 cm and/or cervical effacement\>80%

    Post labor- up to 24 hours

Secondary Outcomes (4)

  • Delivery within 24 hours

    post-labor - up to 24 hours

  • Cesarean section rate

    post labor - up to 24 hours

  • Maternal complications

    participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days

  • Neonatal complications

    Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month

Study Arms (2)

PGE2

ACTIVE COMPARATOR

Patients allocated to vaginal PGE2 (Prostin) for cervical ripening

Drug: Prostin (PGE2) tablets

Foley catheter

ACTIVE COMPARATOR

Patients allocated to foley catheter placement for cervical ripening

Device: Foley catheter

Interventions

Prostin (PGE2) tabletsDRUG
PGE2
Foley catheterDEVICE
Foley catheter

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton term pregnancies (\>37 weeks), vertex presentation
  • Intact membranes
  • Low Bishop score (\<7)
  • First, second or third delivery
  • Medical indication for induction
  • Viable fetus

You may not qualify if:

  • Contraindication for vaginal delivery, for PGE2 or foley catheter
  • Gestational age\<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Wolfson Medical Center

Holon, Israel

RECRUITING

MeSH Terms

Interventions

KLK15 protein, humanDinoprostoneTablets

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsDosage FormsPharmaceutical Preparations

Central Study Contacts

Hadas Ganer Herman, MD

CONTACT

972526206696hadassganer@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 22, 2015

First Posted

July 1, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations

IL(1)