Induction ATAD Catheter and Lower Segment Thickness

NCT ID: NCT06187779

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2026-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Induction of Labor Affected Fetus / Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Segmental thickness measurement

This population's lower segment will be measured.

Group Type EXPERIMENTAL

Lower segment measurment

Intervention Type OTHER

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

Segmental thickness no measurement

No measurements of lower segment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lower segment measurment

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MEIRATAD

Identifier Type: -

Identifier Source: org_study_id

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