NCT04597333

Brief Summary

Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

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

October 15, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

October 15, 2020

Last Update Submit

April 19, 2022

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (2)

  • Delivery within 24 hours.

    Rate of delivery in 24 hours.

    From the time of induction up to 24 hours from induction.

  • Time to delivery.

    The number of hours it takes to deliver.

    From the time of induction up to 120 hours from induction.

Secondary Outcomes (4)

  • Mode of delivery.

    From the time of induction up to 120 hours from induction.

  • Uterine revision.

    From the time of induction up to 120 hours from induction.

  • Postpartum hemorrhage.

    From the time of induction up to 120 hours from induction.

  • Chorioamnionitis.

    From the time of induction up to 120 hours from induction.

Study Arms (2)

2nd Dinoprostone.

ACTIVE COMPARATOR

Women induced with a second dinoprostone insert.

Drug: Dinoprostone

Cervical ripening balloon.

ACTIVE COMPARATOR

Women induced with a cervical ripening balloon.

Device: Cervical ripening balloon.

Interventions

DinoprostoneDRUG

Dinoprostone vaginal insert.

2nd Dinoprostone.
Cervical ripening balloon.DEVICE

Double lumen cervical ripening balloon.

Cervical ripening balloon.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women after induction of labor with Dinoprostone.
  • BISHOP score of under 5 after 1st induction attempt.
  • Nulliparous women.

You may not qualify if:

  • Women after induction of labor with a cervical ripening balloon.
  • BISHOP score of over 5 after 1st induction attempt.
  • Multiparous women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

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

October 15, 2020

First Posted

October 22, 2020

Study Start

October 15, 2020

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)