Caesarean Scar Defect

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Review clinical trials related to Caesarean Scar Defect. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect

The goal of this clinical trial is to evaluate the efficacy and safety of transvaginal niche resection in improving pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. The main questions it aims to answer are: 1. Does transvaginal niche resection improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility? 2. What medical problems do participants have when taking transvaginal niche resection? Researchers will compare transvaginal niche resection to expectant management (without any additional surgical intervention) to see if transvaginal niche resection works to improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. Participants will: 1. Undergo a procedure (transvaginal niche resection) within 2 week after randomization in the intervention group. Women were advised to use contraception in the first 6 months following niche resection to allow uterine healing prior to subsequent pregnancy. 2. Receive usual care at least 9 months which means no additional surgical intervention during this period in the control group. Patients are allowed to become pregnant and to receive fertility therapies if indicated. Any member of the control group who has not become pregnant after 9 months will be given the opportunity to undergo a transvaginal niche resection. 3. Receive a standardized magnetic resonance imaging (MRI) evaluation of the niches. Niches will be evaluated at baseline in all groups and at 3 months after surgery. 4. Be contacted by telephone at 6, 9 and 15 months to assess the primary and secondary outcomes.

Participants needed: 100
Trial details
Age: 19-48Biological sex: FemaleType: InterventionalSponsor: International Peace Maternity and Child Health HospitalUpdated: Sep 24, 2024
Eligibility criteria

It was diagnosed by MRI as a large niche (defined as niche with a depth of >5... [+3]

Age below 18 years or over 49 years; [+6]