[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07634679":3,"trial-entities:NCT07634679":146,"trial-summary:NCT07634679":149},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":18,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":38,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":79,"locations":82,"central_contacts":104,"overall_officials":106,"references":110,"see_also_links":145},"NCT07634679","2025-17472","Impact of a Bladder Flap on Cesarean Scar Niche Development","NOT_YET_RECRUITING","2032-05-01","2026-07","2026-07-20","Montefiore Medical Center","OTHER",true,"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.","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\n\nBladder 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.\n\nPrevious 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.",[17],"Cesarean Scar Defect",[19],"Isthmocele","INTERVENTIONAL","PREVENTION",[23],"NA",{"count":25,"type":26},130,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"PROCEDURE","Bladder flap formation","Participants in this arm will have a bladder flap completed at the time of their cesarean delivery.",[30],[34],{"measure":35,"description":36,"timeFrame":37},"Presence of cesarean scar niche","A dichotomous measure of the presence or absence of a cesarean scar niche, as defined by a residual myometrial thickness of \\\u003C3mm 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.","From enrollment to transvaginal ultrasound, completed approximately 6-8 weeks postpartum",[39,43,46,49,53,56,59],{"measure":40,"description":41,"timeFrame":42},"Distance of cesarean scar niche from internal os","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",{"measure":44,"description":45,"timeFrame":42},"Size of cesarean scar niche","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.",{"measure":47,"description":48,"timeFrame":42},"Measurement of residual myometrium","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.",{"measure":50,"description":51,"timeFrame":52},"Size of cesarean scar defect in subsequent 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.","From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancy",{"measure":54,"description":55,"timeFrame":52},"Cases of abnormal placentation in subsequent pregnancies","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.",{"measure":57,"description":58,"timeFrame":42},"Uterine Position\u002FFlexion","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",{"measure":60,"description":61,"timeFrame":42},"Number\u002Fpercentage of Operative and Postoperative Complications","Patient charts will be reviewed to summarize the number\u002Fpercentage of surgical complications in each arm. This includes complications such as damage to surrounding structures, hemorrhage, hematoma formation, surgical site infections.","FEMALE","18 Years",null,false,{"inclusion":67,"exclusion":72,"raw_text":78},[68,69,70,71],"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",[73,74,75,76,77],"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\u002Foutside the lower uterine segment at time of surgery","Hysterectomy is indicated prior to postpartum follow-up","Inclusion Criteria:\n\n* Age 18 years or older\n* Primary low transverse cesarean section performed at Montefiore Weiler or Wakefield Hospitals\n* Able to provide informed consent in English or Spanish\n* Plan for postpartum care at Montefiore Medical Center\n\nExclusion Criteria:\n\n* History of a prior uterine surgery\n* Known congenital uterine anomalies\n* Inability to safely access lower uterine segment at time of delivery\n* Hysterotomy is extended past\u002Foutside the lower uterine segment at time of surgery\n* Hysterectomy is indicated prior to postpartum follow-up",[80,81],"ADULT","OLDER_ADULT",[83,98],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":95},"Jack D. Weiler Hospital - Einstein Campus","The Bronx","New York","10461","United States",[90],{"name":91,"role":92,"phone":93,"email":94},"Alyssa Yeung, MD","CONTACT","574-329-8771","ayeung@montefiore.org",{"lat":96,"lon":97},40.84985,-73.86641,{"facility":99,"city":85,"state":86,"zip":100,"country":88,"contacts":101,"geoPoint":103},"Montefiore Einstein Hospital - Wakefield Campus","10466",[102],{"name":91,"role":92,"phone":93,"email":94},{"lat":96,"lon":97},[105],{"name":91,"role":92,"phone":93,"email":94},[107],{"name":108,"affiliation":11,"role":109},"Pe'er Dar, MD","PRINCIPAL_INVESTIGATOR",[111,115,118,121,124,127,130,133,136,139,142],{"pmid":112,"type":113,"citation":114},"33220003","BACKGROUND","Kamel R, Thilaganathan B. Time to reconsider elective Cesarean birth. Ultrasound Obstet Gynecol. 2021 Mar;57(3):363-365. doi: 10.1002\u002Fuog.22158. No abstract available.",{"pmid":116,"type":113,"citation":117},"23448347","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\u002F1471-0528.12148. Epub 2013 Feb 28.",{"pmid":119,"type":113,"citation":120},"29521289","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\u002F0366-6999.226902.",{"pmid":122,"type":113,"citation":123},"24411951","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\u002Fj.ejogrb.2013.12.020. Epub 2013 Dec 22.",{"pmid":125,"type":113,"citation":126},"22395144","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\u002FAOG.0b013e31824c0e12.",{"pmid":128,"type":113,"citation":129},"27032737","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\u002Fj.jogc.2015.12.009. Epub 2016 Mar 2.",{"pmid":131,"type":113,"citation":132},"4167498","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\u002F0002-9378(67)90292-x.",{"pmid":134,"type":113,"citation":135},"32330331","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\u002Fuog.22053.",{"pmid":137,"type":113,"citation":138},"37506497","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\u002Fj.bpobgyn.2023.102390. Epub 2023 Jul 15.",{"pmid":140,"type":113,"citation":141},"28599899","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\u002Fj.ajog.2017.05.067. Epub 2017 Jun 24.",{"pmid":143,"type":113,"citation":144},"37216058","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\u002Fhsr2.1274. eCollection 2023 May.",[],{"nct_id":4,"conditions":147,"biomarkers":148},[17],[],{"nct_id":4,"found":65,"summary":64,"prompt_version":64}]