Does an Educational Video Increase Trial of Labor After Cesarean and Reduce Anxiety Among Women With a Prior Cesarean? A Randomized Controlled Trial
| Registry | NCT07338747 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 90 (Estimated) |
| Sponsor | Wolfson Medical Center (Other gov) |
| Conditions | Anxiety, TOLAC, Previous Cesarean Delivery, Trial of Labor After Cesarean |
| Interventions | Video-Based Educational Intervention, Standard Verbal Counseling (Behavioral, other) |
| Dates | start 2026-01-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-01-14, last updated 2026-01-14 |
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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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental: Video-Based Patient Education | Experimental | Behavioral: Video-Based Educational Intervention | Participants receive structured video-based education regarding trial of labor after cesarean. |
| Active Comparator: Standard Verbal Counseling | Active comparator | Other: Standard Verbal Counseling | Participants receive standard verbal counseling regarding trial of labor after cesarean. |
Sex: Female, ages: 18 Years to any
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.