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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Maternal Anxiety Level [Срок оценки: Immediately after completion of counseling.]

Вторичные конечные точки (4)

• Patient Knowledge Regarding Trial of Labor After Cesarean [Срок оценки: Immediately after completion of counseling.]
• Rate of Successful Trial of Labor After Cesarean (TOLAC) [Срок оценки: From delivery.]
• Patient Satisfaction With Counseling Method [Срок оценки: Immediately after completion of counseling.]
• Maternal Preference for Trial of Labor After Cesarean Versus Elective Repeat Cesarean Delivery [Срок оценки: Immediately after completion of counseling.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07338747 · WOMC-0175-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗