Educational Video, Anxiety, and Mode of Delivery After Previous Cesarean

NCT ID: NCT07338747

Last Updated: 2026-01-14

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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This interventional study evaluates whether video-based patient education regarding Trial of Labor After Cesarean (TOLAC) reduces maternal anxiety compared with standard verbal counseling. Pregnant women eligible for TOLAC will be randomized to receive either a structured educational video or routine verbal counseling. Maternal anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI).

Detailed Description

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Trial of labor after cesarean (TOLAC) is a complex clinical decision that may be associated with significant maternal anxiety. Adequate counseling is essential to support informed decision-making; however, the optimal method for delivering information remains unclear.

This randomized interventional study aims to assess whether video-based patient education can reduce anxiety levels compared with standard verbal counseling. Eligible pregnant women planning delivery after a previous cesarean section will be randomly assigned to one of two study arms: video-based educational counseling or standard verbal counseling.

Anxiety will be measured using the validated State-Trait Anxiety Inventory (STAI) questionnaire after counseling. The results of this study may inform future strategies for patient counseling and shared decision-making in women considering TOLAC.

Conditions

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Anxiety TOLAC Previous Cesarean Delivery Trial of Labor After Cesarean

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Evaluation of the effect of video-based patient education on maternal anxiety levels prior to trial of labor after cesarean.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental: Video-Based Patient Education

Participants receive structured video-based education regarding trial of labor after cesarean.

Group Type EXPERIMENTAL

Video-Based Educational Intervention

Intervention Type BEHAVIORAL

A structured educational video providing information on benefits, risks, and expectations of trial of labor after cesarean.

Active Comparator: Standard Verbal Counseling

Participants receive standard verbal counseling regarding trial of labor after cesarean.

Group Type ACTIVE_COMPARATOR

Standard Verbal Counseling

Intervention Type OTHER

Routine verbal counseling provided by the treating clinician regarding trial of labor after cesarean.

Interventions

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Video-Based Educational Intervention

A structured educational video providing information on benefits, risks, and expectations of trial of labor after cesarean.

Intervention Type BEHAVIORAL

Standard Verbal Counseling

Routine verbal counseling provided by the treating clinician regarding trial of labor after cesarean.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with a singleton pregnancy.
* History of one previous cesarean delivery with a low transverse uterine incision.
* Eligible for a trial of labor after cesarean (TOLAC) according to clinical assessment and Israeli national clinical guidelines.
* Age 18 years or older.
* Hebrew-speaking.
* Ability and willingness to provide written informed consent.

Exclusion Criteria

* Medical or obstetric conditions contraindicating vaginal delivery, including but not limited to placenta previa or marginal placenta previa.
* History of uterine surgery other than one prior low transverse cesarean section that precludes vaginal delivery.
* History of two or more prior cesarean deliveries.
* Non-vertex fetal presentation or any presentation unsuitable for a trial of labor.
* Multiple gestation.
* Diagnosed severe anxiety disorder or other significant psychiatric disorder that may interfere with participation in the study or completion of questionnaires.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shir Lev, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Central Contacts

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Shir Lev, MD

Role: CONTACT

+972504598339

Other Identifiers

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WOMC-0175-25

Identifier Type: -

Identifier Source: org_study_id

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