- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07338747
Educational Video, Anxiety, and Mode of Delivery After Previous Cesarean
Does an Educational Video Increase Trial of Labor After Cesarean and Reduce Anxiety Among Women With a Prior Cesarean? A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shir Lev, MD
- Phone Number: +972504598339
- Email: shirlevv@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Video-Based Patient Education
Participants receive structured video-based education regarding trial of labor after cesarean.
|
A structured educational video providing information on benefits, risks, and expectations of trial of labor after cesarean.
|
|
Active Comparator: Active Comparator: Standard Verbal Counseling
Participants receive standard verbal counseling regarding trial of labor after cesarean.
|
Routine verbal counseling provided by the treating clinician regarding trial of labor after cesarean.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Anxiety Level
Time Frame: Immediately after completion of counseling.
|
Assessment of maternal anxiety using the State-Trait Anxiety Inventory (STAI) questionnaire.
|
Immediately after completion of counseling.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Knowledge Regarding Trial of Labor After Cesarean
Time Frame: Immediately after completion of counseling.
|
Assessment of patient knowledge regarding trial of labor after cesarean, based on a structured questionnaire developed for the study.
|
Immediately after completion of counseling.
|
|
Rate of Successful Trial of Labor After Cesarean (TOLAC)
Time Frame: From delivery.
|
Proportion of participants who achieved a successful vaginal birth following a trial of labor after cesarean.
|
From delivery.
|
|
Patient Satisfaction With Counseling Method
Time Frame: 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.
|
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.
|
Participant-reported preference for mode of delivery (trial of labor after cesarean versus elective repeat cesarean delivery) following counseling.
|
Immediately after completion of counseling.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shir Lev, MD, Wolfson Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WOMC-0175-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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