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Набор скоро начнётся NCT07575490

Impact of Post-Cesarean Abdomino-Pelvic Training on Diastasis Recti and Sexual Function

Без фазы С лечением Diastasis Recti Abdominis Postpartum Period Cesarean Section Sexual Dysfunction, Physiological Pelvic Floor Muscle Training

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Abdomino-Pelvic Power-Training Program, Standard Postpartum Follow-up.
Кому может быть актуально
Состояния в реестре: Diastasis Recti Abdominis Postpartum Period Cesarean Section Sexual Dysfunction, Physiological Pelvic Floor Muscle Training. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Impact of Structured Postoperative Abdomino-Pelvic Power-Training on Diastasis Recti Abdominis, Pelvic Hemodynamics, and Sexual Function Following Cesarean Section: A Prospective, Randomized Controlled, Doppler Morphometric Analysis Study

Обзор

This study aims to investigate the effects of a specific exercise program on physical recovery and sexual health in women who have had a cesarean section. Pregnancy and abdominal surgery can lead to a separation of the abdominal muscles, known as Diastasis Recti Abdominis (DRA), and may affect pelvic health and sexual function. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in a 6-week "Structured Abdomino-Pelvic Power-Training" program starting at the 6th week after surgery. This program includes specific exercises to strengthen the core and pelvic floor muscles. The control group will follow the standard routine postpartum care. The researchers will use ultrasound and Doppler imaging to measure the distance between the abdominal muscles and the blood flow in the pelvic area at the beginning of the study and after 6 weeks of training. Participants will also complete a validated questionnaire (FSFI) to evaluate their sexual function. The goal of the research is to determine if this structured exercise program helps close the abdominal gap more effectively and improves pelvic blood flow and sexual well-being compared to standard care.

Подробное описание

Background and Rationale:

Cesarean section (C-section) is a major surgical procedure that alters the integrity of the abdominal wall. Even if it avoids direct pelvic floor trauma associated with vaginal delivery, the combination of pregnancy-related mechanical stress and surgical incision often leads to Diastasis Recti Abdominis (DRA) and pelvic floor dysfunction. These conditions are frequently associated with reduced sexual function and lower quality of life in the postpartum period. While pelvic floor muscle training (PFMT) is well-studied, there is a lack of objective evidence regarding the impact of structured "Abdomino-Pelvic Power-Training" on tissue-level recovery and vascular perfusion. Study Objectives:

The primary objective of this prospective, randomized controlled study is to evaluate the efficacy of a 6-week structured rehabilitation program on inter-recti distance (IRD), pelvic hemodynamics, and sexual function in primiparous women following elective C-section. Methodology and Intervention:

A total of 160 participants will be recruited at their 6th-week postpartum visit at Harran University Hospital. Eligible participants will be randomized into two groups: Intervention Group: Participants will receive a 6-week structured abdomino-pelvic power-training protocol (including PFMT and core stabilization exercises). The program consists of weekly clinical visits and a prescribed home exercise regimen. Control Group: Participants will receive standard routine postpartum follow-up care without specific exercise training. Outcome Measures and Evaluation:

Assessments will be performed at baseline (6th week postpartum) and at the end of the intervention (3rd month postpartum). Morphometric Analysis: Inter-recti distance (IRD) will be measured using linear probe ultrasonography. Hemodynamic Assessment: Pelvic blood flow will be evaluated via Doppler ultrasonography, measuring Pulsatility Index (PI) and Resistance Index (RI) of the Uterine Artery and Vaginal Artery, as well as perfusion of the surgical scar tissue. Functional Assessment: Sexual function will be measured using the validated Female Sexual Function Index (FSFI) questionnaire. Statistical Analysis:

Data will be analyzed using SPSS software. Continuous variables will be compared using Independent Samples t-test or Mann-Whitney U test between groups, and Paired Samples t-test or Wilcoxon Signed-Rank test for within-group changes over time. Correlation between objective Doppler parameters and subjective FSFI scores will be evaluated.

Вмешательства

  • Другое Abdomino-Pelvic Power-Training Program
    A 6-week structured exercise program including one weekly supervised clinical session and daily home exercises. It focuses on core stabilization (rectus abdominis, obliques, transversus abdominis) to reduce inter-recti distance and Pelvic Floor Muscle Training (PFMT) to improve strength and hemodynamics.
  • Другое Standard Postpartum Follow-up
    Participants will follow the routine clinical postpartum follow-up protocol. This includes standard medical advice and assessments at the 6th week and 3rd month postpartum, without participation in the structured exercise program.

Первичные конечные точки

  • Change in Inter-recti Distance (IRD) [Срок оценки: From baseline (6th week postpartum) to the completion of the exercise program (3rd month postpartum).]

Критерии участия

Inclusion Criteria:Primiparous women (first-time mothers).

Women who have undergone an elective cesarean section.

Participants who are at their 6th week postpartum at the start of the study.

Aged between 18 and 45 years.

Volunteering to participate and capable of signing the informed consent form.

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Критерии исключения

  • Multiparous women (those with more than one delivery).

Women with a history of previous abdominal or pelvic surgery (other than the current C-section).

Presence of chronic diseases (e.g., uncontrolled diabetes, hypertension, or connective tissue disorders).

Any musculoskeletal or neurological condition that prevents participation in an exercise program.

History of pelvic organ prolapse or severe urinary incontinence prior to pregnancy.

Active pelvic or abdominal infection.

Participants who have already started a structured postpartum exercise program elsewhere.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 2 центра
  • Harran University Research and Application Hospital — Sanliurfa
  • Harran University Research and Application Hospital — Şanliurfa

Идентификаторы

NCT: NCT07575490 · HRÜ/26.04.16

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗