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NCT06187779 Clinical Trial

Induction ATAD Catheter and Lower Segment Thickness

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:
Influence of Lower Segment Thickness on Induction of Labor With Balloon Insertion (ATAD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06187779
Other study ID # MEIRATAD
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 6, 2023
Est. completion date December 6, 2026

Study information
Verified date December 2023
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date December 6, 2026
Est. primary completion date December 6, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Gestational age above 24 weeks - Singleton - Vertex position - Labor induction based on obstetrics guidelines Exclusion Criteria: - C/I for Induction of labor - C/I for vaginal birth - Multiple gestation - Known fetal anatomical or genetic anomalies.

Study Design

Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn

Intervention

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

Locations
Country Name City State
Israel Meir Medical Center Kfar Saba

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cesarean section prevalence Number of patients who delivered with CS during labor
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