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Niche In CEsarean Scar Trial (NICEST)

RecruitingNAAges 18 Years - 60 YearsFemaleNguyen Thi Thu Ha
NCT05312775 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Objective: To compare the effect of uterine closure techniques during CD on the formation of Niche evaluated on transvaginal ultrasound and gynecological complications. Study design: a double-blinded, single-center, randomized clinical trial. Setting: Hanoi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pregnant women who undergo a primary CD (planned or unplanned) * Age ≥ 18 years. * Gestational age ≥ 37 0/7 weeks Exclusion Criteria: * Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection). * Women with abnormal menstrual bleeding (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation, drugs, polyps, fibroids, etc.). * Women with dysmenorrhea, dyspareunia, suprapubic pain. * Abnormal placenta: Placenta privia, Placenta percreta… in the current pregnancy.
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What it tests

  • Double-layer uterine closure
  • Single-layer uterine closure
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Where

1 site
Hanoi Obstetrics and Gynecology Hospital
Hanoi, Vietnam
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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