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

NCT07338747 | Not Yet Recruiting

• 1 other identifier: WOMC-0175-25
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Anxiety; TOLAC; Previous Cesarean Delivery; Trial of Labor After Cesarean

Outcome Measures

Primary Outcomes (1)

• Maternal Anxiety Level

  Assessment of maternal anxiety using the State-Trait Anxiety Inventory (STAI) questionnaire.

  Immediately after completion of counseling.

Secondary Outcomes (4)

• Patient Knowledge Regarding Trial of Labor After Cesarean

  Immediately after completion of counseling.

• Rate of Successful Trial of Labor After Cesarean (TOLAC)

  From delivery.

• Patient Satisfaction With Counseling Method

  Immediately after completion of counseling.

• Maternal Preference for Trial of Labor After Cesarean Versus Elective Repeat Cesarean Delivery

  Immediately after completion of counseling.

Study Arms (2)

Experimental: Video-Based Patient Education

EXPERIMENTAL

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

Behavioral: Video-Based Educational Intervention

Active Comparator: Standard Verbal Counseling

ACTIVE COMPARATOR

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

Other: Standard Verbal Counseling

Interventions

Video-Based Educational Intervention BEHAVIORAL

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

Experimental: Video-Based Patient Education

Standard Verbal Counseling OTHER

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

Active Comparator: Standard Verbal Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wolfson Medical Center: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Shir Lev, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shir Lev, MD

CONTACT

+972504598339; shirlevv@gmail.com

Study Design

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

Model Details: Evaluation of the effect of video-based patient education on maternal anxiety levels prior to trial of labor after cesarean.

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share