A Comparison Between Bladder Dissection Before and After Uterine Incision During Cesarean Section for Placenta Accreta Spectrum: A Randomized Controlled Study

Обзор

The worldwide incidence of placenta accreta spectrum is increasing, following the trend of rising caesarean delivery. It is an heterogeneous condition associated with a high maternal morbidity and mortality rate (Jauniaux et al., 2018). caesarean hysterectomy is considered the gold standard for the treatment of placenta accreta. Also this radical approach is associated with high rates of severe maternal morbidity as hemorrhage and insult to surrounding organs during surgery (Hoffman et al., 2010). Surgeons should be able to dissect the bladder safely and confidently through minimally invasive techniques, to avoid surgical injury, it is important to use anatomic landmarks, minimize the use of cauterization (Farhat and Casale, 2018). All centers are encouraged to develop guidelines to manage the potential urologic complications of these cases tailored to their resources (Taneja and Shah, 2017). This study aims to evaluate the timing of bladder dissection in caesarean section in patient with placenta accreta spectrum.

Подробное описание

Objective:

Try to provide preliminary data to judge between two different approaches during caesarean section for morbidly adherent placenta, that's are bladder dissection before and after uterine incision as regard operative time, blood loss, and incidence of urological injuries.

Research Question:

\- Does bladder dissection after uterine incision in caesarean sections with PAS avoids bladder injuries compared to bladder dissection before uterine incision and does it affects operative time and blood loss.

Research hypothesis:

* Null Hypothesis (H₀): There is no significant difference in performing bladder dissection prior nor after uterine incision in caesarean sections with PAS * Alternative Hypothesis (H₁):. bladder dissection before uterine incision in caesarean sections with PAS has superior outcomes compared to bladder dissection after uterine incision.

Вмешательства

• Процедура bladder dissection in placenta accreta spectrum
  All caesarean sections will be performed by a surgeon who has experience in performing caesarean hysterectomy in both groups. * Scrubbing the abdomen as usual. * Subumblical midline skin incision versus Pfannenstiel incision will be chosen according to site of the placenta and previous surgeries. * In group A careful bladder dissection will be done before uterine incision with ensuring hemostasis, uterine incision will be done above the placenta, after delivering the baby awaiting for placental

Первичные конечные точки

• o Blood loss [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Women with BMI at or under 35kg/m2
• Women with history of at least previous two caesarean section
• Gestational age more than 32 weeks with viable fetus.
• Women with any degree of placenta previa.
• Women with placenta falling in the PAS.
• Willing and able to provide informed consent.

Критерии исключения

• o History of urinary bladder injury.

• History of urinary or renal disorders
• Women with coagulation disorders or on anticoagulation therapy.
• Patients who are hemodynamically unstable before skin incision

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

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Eller AG, Porter TF, Soisson P, Silver RM. Optimal management strategies for placenta accreta. BJOG. 2009 Apr;116(5):648-54. doi: 10.1111/j.1471-0528.2008.02037.x. Epub 2009 Feb 4. PMID 19191778
• Hoffman MS, Karlnoski RA, Mangar D, Whiteman VE, Zweibel BR, Lockhart JL, Camporesi EM. Morbidity associated with nonemergent hysterectomy for placenta accreta. Am J Obstet Gynecol. 2010 Jun;202(6):628.e1-5. doi: 10.1016/j.ajog.2010.03.021. PMID 20510963
• Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24. PMID 28599899
• Marshall NE, Fu R, Guise JM. Impact of multiple cesarean deliveries on maternal morbidity: a systematic review. Am J Obstet Gynecol. 2011 Sep;205(3):262.e1-8. doi: 10.1016/j.ajog.2011.06.035. Epub 2011 Jun 15. PMID 22071057

Идентификаторы

NCT: NCT06957184 · bladder disection in PAS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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