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Not yet recruiting NCT07338747

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

No phase Interventional Anxiety TOLAC Previous Cesarean Delivery Trial of Labor After Cesarean

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video-Based Educational Intervention, Standard Verbal Counseling.
Who it may be relevant to
Registry conditions: Anxiety, TOLAC, Previous Cesarean Delivery, Trial of Labor After Cesarean. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • Behavioral Video-Based Educational Intervention
    A structured educational video providing information on benefits, risks, and expectations of trial of labor after cesarean.
  • Other Standard Verbal Counseling
    Routine verbal counseling provided by the treating clinician regarding trial of labor after cesarean.

Primary outcome measures

  • Maternal Anxiety Level [Time frame: Immediately after completion of counseling.]
Secondary outcome measures (4)
  • Patient Knowledge Regarding Trial of Labor After Cesarean [Time frame: Immediately after completion of counseling.]
  • Rate of Successful Trial of Labor After Cesarean (TOLAC) [Time frame: From delivery.]
  • Patient Satisfaction With Counseling Method [Time frame: Immediately after completion of counseling.]
  • Maternal Preference for Trial of Labor After Cesarean Versus Elective Repeat Cesarean Delivery [Time frame: Immediately after completion of counseling.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07338747 · WOMC-0175-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗