NCT03033264

Brief Summary

Women with a BMI\>30 and women with a BMI\<30 will be divided in a randomized controlled manor to 4 groups depending on the mode of labor induction and BMI value:

  1. 1.Dinoprostone in women with a BMI\>30.
  2. 2.Dinoprostone in women with a BMI\<30.
  3. 3.Cervical ripening balloon in women with a BMI\>30.
  4. 4.Cervical ripening balloon in women with a BMI\<30. The subjects will be followed until labor, and information regarding the success of induction, mode of delivery and time of delivery will be collected from patients' electronic files.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

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

December 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3.6 years

First QC Date

December 24, 2016

Last Update Submit

October 15, 2020

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

  • Mode of delivery

    Vaginal delivery in oppose to cesarean section.

    Up to 5 days.

Secondary Outcomes (3)

  • Time to delivery

    Up to 5 days.

  • Induction success.

    Up to 5 days.

  • Neonatal complications and outcome.

    Up to 5 days.

Study Arms (4)

BMI>30+Dinoprostone

EXPERIMENTAL

Women with a BMI\>30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.

Drug: Dinoprostone

BMI<30+Dinoprostone

EXPERIMENTAL

Women with a BMI\<30 at term that will be induced for obstetrical indications with 10 mg of a Dinoprostone vaginal insert.

Drug: Dinoprostone

BMI>30+Cervical ripening balloon

EXPERIMENTAL

Women with a BMI\>30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.

Device: Double lumen cervical ripening balloon.

BMI<30+Cervical ripening balloon

EXPERIMENTAL

Women with a BMI\<30 at term that will be induced for obstetrical indications with a double lumen cervical ripening balloon.

Device: Double lumen cervical ripening balloon.

Interventions

DinoprostoneDRUG

10 mg of a Dinoprostone vaginal insert.

Also known as: Prostaglandin E2
BMI<30+DinoprostoneBMI>30+Dinoprostone
Double lumen cervical ripening balloon.DEVICE

Double lumen cervical ripening balloon.

BMI<30+Cervical ripening balloonBMI>30+Cervical ripening balloon

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Any pregnant woman at term with an obstetric indication for labor induction.

You may not qualify if:

  • Previous cesarean section.
  • Positive Oxytocin challenge test.
  • Positive contraction stress test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

Related Publications (1)

  • 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

  • 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

December 24, 2016

First Posted

January 26, 2017

Study Start

January 1, 2017

Primary Completion

July 31, 2020

Study Completion

October 1, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)