Anxiety, Previous Cesarean Delivery, TOLAC, Trial of Labor After Cesarean
Conditions
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).
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
BEHAVIORALVideo-Based Educational Intervention
A structured educational video providing information on benefits, risks, and expectations of trial of labor after cesarean.
OTHERStandard Verbal Counseling
Routine verbal counseling provided by the treating clinician regarding trial of labor after cesarean.
Sponsors
Wolfson Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Evaluation of the effect of video-based patient education on maternal anxiety levels prior to trial of labor after cesarean.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Anxiety Level | Immediately after completion of counseling. | Assessment of maternal anxiety using the State-Trait Anxiety Inventory (STAI) questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactShir Lev, MD
Outcome results
None listed