Impact of a Bladder Flap on Cesarean Scar Niche Development (B-FIND)
10 сентября 2026 г. обновлено: Montefiore Medical Center
The goal of this trial is to examine if the completion or omission of a bladder flap impacts the location and formation of cesarean scar niche in women undergoing primary cesarean section.
The main question it aims to answer is if omission of a bladder flap changes the prevalence of cesarean scar niche on a 6-8 week postpartum ultrasound.
Researchers will compare participants that have a bladder flap made to those that have a bladder flap omitted at time of their primary cesarean delivery.
Participants will have routine postpartum care and be asked to return for a 6-8 week postpartum transvaginal ultrasound.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Подробное описание
As the rate of cesarean deliveries increases globally, the importance of a cesarean scar niche (CSN) has evolved into a significant clinical concern with long term obstetric and gynecologic implications including increasing risk for placenta accreta spectrum (PAS) in future pregnancies and abnormal uterine bleeding. In fact, the main cause of PAS is placentation into uterine scars secondary to cesarean deliveries
Bladder flap formation is a standard step in cesarean deliveries and involves dissecting the bladder off the uterus to push it inferiorly to allow better access to the lower uterine segment for hysterotomy and decrease risk of bladder injury. The lower uterine segment is targeted for hysterotomy as it has been shown that the proportion of muscle tissue and the thickness of the wall of the uterus increases as one travels from the cervix to the fundus. Therefore, by making an incision in the lower uterine segment, the surgeon has less tissue to go through to deliver the fetus and disrupts less muscle to preserve uterine myometrial integrity. While studies have suggested bladder flap omission in primary cesarean deliveries does not increase intraoperative complications and reduces operating time. CSN assessment was not an outcome evaluated in these studies and the decision to omit or perform a bladder flap is at the discretion of the surgeon.
Previous studies have looked at different surgical techniques and different cervical dilations at time of cesarean delivery and the impact on niche formation and location. There has been no consensus on hysterotomy or other surgical techniques to decrease risk of CSN formation. To our knowledge, there have not been studies that have assessed postoperative CSN in relation to completion or omission of a bladder flap prior to hysterotomy. As such, the investigator team hypothesizes that omission of a bladder flap lends itself to a more cephalad hysterotomy and potentially more clinically significant CSNs.
Тип исследования
Интервенционный
Регистрация (Оцененный)
338
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Alyssa Yeung, MD
- Номер телефона: 574-329-8771
- Электронная почта: ayeung@montefiore.org
Места учебы
-
-
New York
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The Bronx, New York, Соединенные Штаты, 10461
- Рекрутинг
- Jack D. Weiler Hospital - Einstein Campus
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Контакт:
- Alyssa Yeung, MD
- Номер телефона: 574-329-8771
- Электронная почта: ayeung@montefiore.org
-
The Bronx, New York, Соединенные Штаты, 10466
- Рекрутинг
- Montefiore Einstein Hospital - Wakefield Campus
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Контакт:
- Alyssa Yeung, MD
- Номер телефона: 574-329-8771
- Электронная почта: ayeung@montefiore.org
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Age 18 years or older
- Primary low transverse cesarean section performed at Montefiore Weiler or Wakefield Hospitals
- Able to provide informed consent in English or Spanish
- Plan for postpartum care at Montefiore Medical Center
Exclusion Criteria:
- History of a prior uterine surgery
- Known congenital uterine anomalies
- Inability to safely access lower uterine segment at time of delivery
- Hysterotomy is extended past/outside the lower uterine segment at time of surgery
- Hysterectomy is indicated prior to postpartum follow-up
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Bladder flap omission
Participants randomized to this arm will have the bladder flap step omitted prior to low transverse hysterotomy formation.
Participants will not need to alter their postoperative or postpartum care.
|
|
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Экспериментальный: Bladder flap formation
Participants randomized to this arm will have a bladder flap formed using standard procedure during the cesarean delivery prior to low transverse hysterotomy and delivery of the infant.
As with the 'Bladder flap omission' arm, participants will not need to alter their postoperative or postpartum care.
|
Participants in this arm will have a bladder flap completed at the time of their cesarean delivery.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Presence of cesarean scar niche
Временное ограничение: From enrollment to transvaginal ultrasound, completed approximately 6-8 weeks postpartum
|
A dichotomous measure of the presence or absence of a cesarean scar niche, as defined by a residual myometrial thickness of <3mm at the scar level, detected on transvaginal ultrasound.
The presence of a cesarean scar niche increases risk for gynecologic complaints and abnormal placentation in subsequent pregnancies.
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From enrollment to transvaginal ultrasound, completed approximately 6-8 weeks postpartum
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Distance of cesarean scar niche from internal os
Временное ограничение: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
|
Sonographic distance of cesarean scar niche from internal cervical os, measured in millimeters, on postpartum transvaginal ultrasound.
The investigator team hypothesizes that a scar further from the internal os has increased risk for abnormal placentation in future pregnancies.
|
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
|
|
Size of cesarean scar niche
Временное ограничение: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
|
Sonographic dimensions of length and width of cesarean scar niche, measured in mm, on transvaginal ultrasound.
The investigator team hypothesizes that larger niches are associated with increased risk of abnormal placentation in future pregnancies and increased risk of future gynecologic complaints.
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From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
|
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Measurement of residual myometrium
Временное ограничение: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
|
Sonographic measurement of residual myometrium in mm by transvaginal ultrasound.
Thinner residual myometrium may imply a larger defect, increased risk for abnormal placentation or formation of a uterine window in future pregnancies.
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From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
|
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Size of cesarean scar defect in subsequent pregnancy
Временное ограничение: From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancy
|
Sonographic measurement of dimensions (length and width) of cesarean scar defect in subsequent pregnancy, measured in mm, to assess if larger postpartum niches are associated with larger defects in subsequent pregnancies as they may carry increased risk of morbidity in the pregnancy.
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From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancy
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Cases of abnormal placentation in subsequent pregnancies
Временное ограничение: From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancy
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If encountered in a subsequent pregnancy, the number of cases of abnormal placentation in the cesarean scar and placenta accreta spectrum will be summarized.
Ultrasound evidence of placenta accreta spectrum include disappearance of the border between placenta and myometrium, placental lacunae, increased vasculature from placenta extending into myometrium, abnormal invasion of placenta into surrounding organs and structures.
Pathology will be used to confirm the number of cases of placenta accreta spectrum.
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From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancy
|
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Uterine Position/Flexion
Временное ограничение: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
|
As an anteverted and retroflexed uterus is commonly the result of a cesarean delivery and scar tissue altering anatomical position, the clinicians will observe if a bladder flap alters position of the uterus.
At the 6 week transvaginal ultrasound, the position of the uterus as anteverted or retroverted and flexion as anteflexed or retroflexed will be recorded.
In the sagittal plane on transvaginal ultrasound, if the cervix appears on the viewer's right or left, the position is anteverted or retroverted, respectively.
The anterior or posterior flexion of the fundus will define anteflexion and retroflexion, respectively
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From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
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Number/percentage of Operative and Postoperative Complications
Временное ограничение: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
|
Patient charts will be reviewed to summarize the number/percentage of surgical complications in each arm.
This includes complications such as damage to surrounding structures, hemorrhage, hematoma formation, surgical site infections.
|
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Pe'er Dar, MD, Montefiore Medical Center
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
- Tuuli MG, Odibo AO, Fogertey P, Roehl K, Stamilio D, Macones GA. Utility of the bladder flap at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2012 Apr;119(4):815-21. doi: 10.1097/AOG.0b013e31824c0e12.
- Fukuda M, Fukuda K, Shimizu T, Bujold E. Ultrasound Assessment of Lower Uterine Segment Thickness During Pregnancy, Labour, and the Postpartum Period. J Obstet Gynaecol Can. 2016 Feb;38(2):134-40. doi: 10.1016/j.jogc.2015.12.009. Epub 2016 Mar 2.
- Angolile CM, Max BL, Mushemba J, Mashauri HL. Global increased cesarean section rates and public health implications: A call to action. Health Sci Rep. 2023 May 18;6(5):e1274. doi: 10.1002/hsr2.1274. eCollection 2023 May.
- Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.
- Kamel R, Thilaganathan B. Time to reconsider elective Cesarean birth. Ultrasound Obstet Gynecol. 2021 Mar;57(3):363-365. doi: 10.1002/uog.22158. No abstract available.
- Kamara M, Henderson JJ, Doherty DA, Dickinson JE, Pennell CE. The risk of placenta accreta following primary elective caesarean delivery: a case-control study. BJOG. 2013 Jun;120(7):879-86. doi: 10.1111/1471-0528.12148. Epub 2013 Feb 28.
- Shi XM, Wang Y, Zhang Y, Wei Y, Chen L, Zhao YY. Effect of Primary Elective Cesarean Delivery on Placenta Accreta: A Case-Control Study. Chin Med J (Engl). 2018 Mar 20;131(6):672-676. doi: 10.4103/0366-6999.226902.
- O'Neill HA, Egan G, Walsh CA, Cotter AM, Walsh SR. Omission of the bladder flap at caesarean section reduces delivery time without increased morbidity: a meta-analysis of randomised controlled trials. Eur J Obstet Gynecol Reprod Biol. 2014 Mar;174:20-6. doi: 10.1016/j.ejogrb.2013.12.020. Epub 2013 Dec 22.
- Rorie DK, Newton M. Histologic and chemical studies of the smooth muscle in the human cervix and uterus. Am J Obstet Gynecol. 1967 Oct 15;99(4):466-9. doi: 10.1016/0002-9378(67)90292-x.
- Kamel R, Eissa T, Sharaf M, Negm S, Thilaganathan B. Position and integrity of uterine scar are determined by degree of cervical dilatation at time of Cesarean section. Ultrasound Obstet Gynecol. 2021 Mar;57(3):466-470. doi: 10.1002/uog.22053.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
15 октября 2026 г.
Первичное завершение (Оцененный)
1 сентября 2027 г.
Завершение исследования (Оцененный)
1 августа 2032 г.
Даты регистрации исследования
Первый отправленный
4 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
4 июня 2026 г.
Первый опубликованный (Действительный)
9 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
10 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2025-17472
- 2025 (Грант/контракт NIH США: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
De-identified individual participant data (IPD) that underlie the results reported in future publications will be made available to qualified researchers upon request
Сроки обмена IPD
Beginning 6 months after trial publication for a period of up to 5 years.
Критерии совместного доступа к IPD
Requests will require a data use agreement and a proposal review by the study team.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .