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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvaginal niche resection | Experimental | The patients assigned to the intervention group will undergo a procedure under general anaesthesia in lithotomy position. |
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| Standard of care | No Intervention | The patients assigned to the control group will receive usual care at least 9 months which means no additional surgical intervention during this period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvaginal niche resection | Procedure | In short: the bladder was carefully dissected away from the uterus towards the abdominal cavity to open the vesicovaginal space and reach the peritoneum. The fingers on the anterior wall isthmus could touch the obvious scar-like defect. The weak scar tissue then thoroughly was removed. |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | Live birth is defined as a live born neonate beyond 24 weeks of gestation. | Total follow-up will extend to 15 months after randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunying Cai | Contact | 086 13621906294 | invain05@163.com |
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