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

NCT07338747 — Not applicable, Not yet recruiting, 90 participants, Wolfson Medical Center

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Does an Educational Video Increase Trial of Labor After Cesarean and Reduce Anxiety Among Women With a Prior Cesarean? A Randomized Controlled Trial

RegistryNCT07338747
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment90 (Estimated)
SponsorWolfson Medical Center (Other gov)
ConditionsAnxiety, TOLAC, Previous Cesarean Delivery, Trial of Labor After Cesarean
InterventionsVideo-Based Educational Intervention, Standard Verbal Counseling (Behavioral, other)
Datesstart 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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-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).

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+Detailed 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.

+Arms and interventions

ArmTypeInterventionsDescription
Experimental: Video-Based Patient EducationExperimentalBehavioral: Video-Based Educational InterventionParticipants receive structured video-based education regarding trial of labor after cesarean.
Active Comparator: Standard Verbal CounselingActive comparatorOther: Standard Verbal CounselingParticipants receive standard verbal counseling regarding trial of labor after cesarean.
  • Video-Based Educational Intervention (Behavioral): A structured educational video providing information on benefits, risks, and expectations of trial of labor after cesarean.
  • Standard Verbal Counseling (Other): Routine verbal counseling provided by the treating clinician regarding trial of labor after cesarean.

+Outcome measures

Primary outcomes

  • Maternal Anxiety Level [Immediately after completion of counseling.]: Assessment of maternal anxiety using the State-Trait Anxiety Inventory (STAI) questionnaire.

Secondary outcomes

  • Patient Knowledge Regarding Trial of Labor After Cesarean [Immediately after completion of counseling.]: Assessment of patient knowledge regarding trial of labor after cesarean, based on a structured questionnaire developed for the study.
  • Rate of Successful Trial of Labor After Cesarean (TOLAC) [From delivery.]: Proportion of participants who achieved a successful vaginal birth following a trial of labor after cesarean.
  • Patient Satisfaction With Counseling Method [Immediately after completion of counseling.]: Patient-reported satisfaction with the counseling method received (video-based education or standard verbal counseling), assessed using a Likert-scale questionnaire.
  • Maternal Preference for Trial of Labor After Cesarean Versus Elective Repeat Cesarean Delivery [Immediately after completion of counseling.]: Participant-reported preference for mode of delivery (trial of labor after cesarean versus elective repeat cesarean delivery) following counseling.

+Eligibility

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.

+Investigators

  • Shir Lev, MD, Principal investigator, Wolfson Medical Center

My Notes