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

W

Wolfson Medical Center (WMC)

Status

Not yet enrolling

Conditions

Previous Cesarean Delivery
TOLAC
Anxiety
Trial of Labor After Cesarean

Treatments

Behavioral: Video-Based Educational Intervention
Other: Standard Verbal Counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT07338747
WOMC-0175-25

Details and patient eligibility

About

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).

Full description

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.

Enrollment

90 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Experimental: Video-Based Patient Education
Experimental group
Description:
Participants receive structured video-based education regarding trial of labor after cesarean.
Treatment:
Behavioral: Video-Based Educational Intervention
Active Comparator: Standard Verbal Counseling
Active Comparator group
Description:
Participants receive standard verbal counseling regarding trial of labor after cesarean.
Treatment:
Other: Standard Verbal Counseling

Trial contacts and locations

0

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Central trial contact

Shir Lev, MD

Data sourced from clinicaltrials.gov

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