Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599671
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect niche a Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TVARES
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None