Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562231
Status:
RECRUITING
Last Update Posted:
None
First Post:
2022-12-20
Brief Title:
Development of Isthmocele Symptom Severity and Quality of Life Scale
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of Isthmocele Symptom Severity and Quality of Life Questionnaire
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Isthmocele also known as cesarean scar defect CSD is the disruption of the integrity of the myometrium in the cesarean section incision and the indentation of the opening in the myometrium towards the visceral peritoneum Residual menstrual blood accumulating in the isthmocele sac can cause chronic endometritis anormal uterine bleeding infertility and chronic pelvic pain
There is currently no quality of life scale that assesses isthmocele symptoms A scale is needed to determine the positive effect on the patients quality of life after the surgeries are performed This study it is aimed to develop a scale that evaluates the severity of isthmocele symptoms and the impact on quality of life due to isthmocele
There is currently no quality of life scale that assesses isthmocele symptoms A scale is needed to determine the positive effect on the patients quality of life after the surgeries are performed This study it is aimed to develop a scale that evaluates the severity of isthmocele symptoms and the impact on quality of life due to isthmocele
Detailed Description:
Patients with isthmocele symptoms three months after cesarean delivery will be included in the studyThe study will not include findings that may be confused with isthmocele symptoms such as uterine fibroids and endometrial polyps Patients with acute vaginitis and pelvic inflammatory disease will not be included in the study
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