NCT03948932

Brief Summary

Pregnant women at term, after 37 weeks' gestation will undergo cervical ripening for labor induction via cervical ripening balloon. Transvaginal sonography will be performed before balloon insertion. During balloon insertion and after uterine balloon inflation a pressure watch will be attached to the balloon and inflation pressures of the vaginal balloon will be measured and documented.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

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

May 8, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

4.4 years

First QC Date

May 8, 2019

Last Update Submit

February 3, 2022

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

  • Volume versus pressure

    To define pressure versus volume characteristics of the expanding uterine cervical balloon.

    From patient admission up to 24 hours postpartum.

Interventions

Transvaginal sonographyDEVICE

Measurement of cervical length via transvaginal sonography prior to labor induction.

Pressure watchDEVICE

Measurement of inflation pressure in a cervical ripening balloon is PSI units.

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women between 24-42 weeks gestation that are candidates for labor induction with a cervical ripening balloon.

You may qualify if:

  • Obstetrical or medical indication for induction of labor
  • Unfavorable cervix
  • Gestational age between 24 - 42 weeks
  • Singleton pregnancy

You may not qualify if:

  • Any contraindication for vaginal delivery
  • Rupture of membranes
  • Fetal malformations incompatible with life
  • Amnionitis
  • Genital viral infection (HIV, HCV, HBV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

RECRUITING

Study Officials

  • Roy Lauterbach, MD

    Rambam healthcare campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roy Lauterbach, MD

CONTACT

0529432416r_lauterbach@rambam.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 14, 2019

Study Start

August 1, 2019

Primary Completion

December 31, 2023

Study Completion

April 1, 2024

Last Updated

February 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)