NCT06187779

Brief Summary

A prospective cohort study of pregnant women undergoing induction of labor at term .inculding- Women with a singleton pregnancy at ≥ 37 weeks' gestation, with a live fetus in cephalic presentation. all women will undergo transvaginal ultrasound assessment before induction of labor admission. Maternal and obstetric characteristics and Bishop score will be recorded. The main outcome is the overall rate of Cesarean delivery after induction of labor.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 6, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2026

Expected
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

December 17, 2023

Last Update Submit

December 17, 2023

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

  • Cesarean section prevalence

    Number of patients who delivered with CS

    during labor

Study Arms (2)

Segmental thickness measurement

EXPERIMENTAL

This population's lower segment will be measured.

Other: Lower segment measurment

Segmental thickness no measurement

NO INTERVENTION

No measurements of lower segment.

Interventions

Lower segment measurmentOTHER

Lower segment measurement will be taken prior to induction with a balloon catheter (ATAD).

Segmental thickness measurement

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFor pregnant patient
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age above 24 weeks
  • Singleton
  • Vertex position
  • Labor induction based on obstetrics guidelines

You may not qualify if:

  • C/I for Induction of labor
  • C/I for vaginal birth
  • Multiple gestation
  • Known fetal anatomical or genetic anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 3, 2024

Study Start

December 6, 2023

Primary Completion

December 6, 2025

Study Completion (Estimated)

December 6, 2026

Last Updated

January 3, 2024

Record last verified: 2023-12

Locations

IL(1)