[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463290":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":42,"locations":50,"responsibleParty":69,"collaborators":24,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":24,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Hanoi Obstetrics and Gynecology Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-layer uterine closure","ACTIVE_COMPARATOR","Women will undergo a CD following a standard way with respect to the mode of hysterotomy, non-closure of the peritoneum. The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included",[13],"Procedure: Single-layer uterine closure",{"label":15,"type":10,"description":16,"interventionNames":17},"Double-layer uterine closure","Women will undergo a CD following a standard way with respect to the mode of hysterotomy, non-closure of the peritoneum. In the intervention group, double-layer closure of the uterus will be performed using unlocked multifilament continuous running sutures for both layers and the endometrial layer will be included in the first layer. The second layer is a continuous running suture that imbricates the first layer",[18],"Procedure: Double-layer uterine closure",[20,25],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","In the intervention group, double-layer closure of the uterus will be performed using unlocked multifilament continuous running sutures for both layers and the endometrial layer will be included in the first layer. The second layer is a continuous running suture that imbricates the first layer",[15],null,{"type":21,"name":9,"description":26,"armGroupLabels":27,"otherNames":24},"The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included",[9],[29,33,37,40],{"name":30,"affiliation":31,"role":32},"Anh D Nguyen, PhD. MD","Hanoi Obstetric and Gynecology Hospital","STUDY_DIRECTOR",{"name":34,"affiliation":35,"role":36},"Yves Ville, PhD. MD","Hôpital Necker-Enfants Malades","STUDY_CHAIR",{"name":38,"affiliation":31,"role":39},"Ha TT Nguyen, PhD.MD","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":31,"role":39},"Giang TT Duong, MD",[43,47],{"name":38,"role":44,"phone":45,"phoneExt":24,"email":46},"CONTACT","0989661093","dr.hanguyen@hogh.vn",{"name":41,"role":44,"phone":48,"phoneExt":24,"email":49},"0084972186390","dttgnts41@gmail.com",[51],{"facility":5,"status":52,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Hanoi","100000","Vietnam","VN",{"type":58,"coordinates":59},"Point",[60,61],105.84117,21.0245,{"lat":61,"lon":60},[64,68],{"name":65,"role":44,"phone":66,"phoneExt":24,"email":67},"Ha TT Nguyen Thi Thu, MD.PhD","0084989661093","thuha.ivf@gmail.com",{"name":41,"role":44,"phone":48,"phoneExt":24,"email":49},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Nguyen Thi Thu Ha","Deputy Director","100463290","niche-in-cesarean-scar-trial-nicest-100463290",false,"NCT05312775","Niche In CEsarean Scar Trial (NICEST)","Single Versus Double-layer Closure of The Cesarean Scar In Niche Development: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Pregnant women who undergo a primary CD (planned or unplanned)\n* Age ≥ 18 years.\n* Gestational age ≥ 37 0\u002F7 weeks\n\nExclusion Criteria:\n\n* Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).\n* Women with abnormal menstrual bleeding (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation, drugs, polyps, fibroids, etc.).\n* Women with dysmenorrhea, dyspareunia, suprapubic pain.\n* Abnormal placenta: Placenta privia, Placenta percreta… in the current pregnancy.",true,"FEMALE","18 Years","60 Years",{"count":85,"type":86},938,"ESTIMATED","INTERVENTIONAL",[89],"NA","Rationale: Cesarean delivery (CD) rates are increasing rapidly worldwide. The consequences of cesarean section not only affect the next pregnancies such as uterine rupture or malplacentation but also cause many gynecological complications or infertility due to the formation of cesarean scar defect (CSD) or Niche. One of the major factors for Niche formation is the techniques of hysterotomy closure at the time of cesarean delivery. Most common hysterotomy closures include single and double layers closure. However, there is limited literature to prove which technique decreases niche creation and associated gynecological complications.\n\nObjective: To compare the effect of uterine closure techniques during CD on the formation of Niche evaluated on transvaginal ultrasound and gynecological complications.\n\nStudy design: a double-blinded, single-center, randomized clinical trial. Setting: Hanoi Obstetrics \\& Gynecology Hospital (HOGH), Viet Nam. Study population: All women at gestational age ≥ 37 0\u002F7 weeks who undergo a primary CD (planned or unplanned).\n\nIntervention: After informed consent, women will be randomized to either unlocked single layer closure or unlocked double-layer closures of cesarean uterine scar in a 1:1 ratio Primary outcome: The proportion of Niche over time (at 6, 12, 18, 24 months after CD) in the two groups.\n\nPower calculation: A sample size of 389 women is needed for each group. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Both uterine closure methods followed by the Vietnam Ministry of Health (VN-MOH), transvaginal ultrasound is also not harmful. It is believed that there are no potential increased risks to patients taking part in this trial because of the standard care and management they receive.",[92],"Niche",[94,95,96],"single-layer uterine closure","double-layer uterine closure","niche","2024-02-28",{"date":99,"type":100},"2024-03-01","ACTUAL",{"date":102,"type":100},"2022-05-01",{"date":104,"type":86},"2026-10",{"name":71,"class":6},1]