Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610864
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Surgical and Obstetric Outcomes in Patients with Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Surgical and Obstetric Outcomes in Patients with Uterine Malformations Undergoing Hysteroscopic Corrective Treatment
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:
MAL_CO
Brief Summary:
The goal of this observational cohort study is to learn if hysteroscopic correction can improve reproductive outcomes in women with uterine malformations The main questions it aims to answer are
Primary hypothesis
-Does hysteroscopic correction significantly improve pregnancy rates at 12 months post-surgery in women with uterine malformations
Secondary hypotheses
Does hysteroscopic correction significantly reduce the rate of first and second-trimester spontaneous abortions
Does hysteroscopic correction significantly increase the live birth rate
In symptomatic patients does hysteroscopic correction significantly reduce dyspareunia and dysmenorrhea
Which patient histopathological and surgical factors are associated with improved obstetric outcomes
Researchers will compare obstetric outcomes pregnancy rate spontaneous abortion rate live birth rate and symptom severity before and after hysteroscopic correction to determine the effectiveness of this surgical intervention
Participants will be women with uterine malformations who underwent hysteroscopic correction at the Digital Hysteroscopy Center of Policlinico Universitario A Gemelli di Roma and Azienda Ospedaliera Universitaria Federico II di Napoli Data will be retrospectively collected and analyzed to assess the impact of surgery on reproductive outcomes
Primary hypothesis
-Does hysteroscopic correction significantly improve pregnancy rates at 12 months post-surgery in women with uterine malformations
Secondary hypotheses
Does hysteroscopic correction significantly reduce the rate of first and second-trimester spontaneous abortions
Does hysteroscopic correction significantly increase the live birth rate
In symptomatic patients does hysteroscopic correction significantly reduce dyspareunia and dysmenorrhea
Which patient histopathological and surgical factors are associated with improved obstetric outcomes
Researchers will compare obstetric outcomes pregnancy rate spontaneous abortion rate live birth rate and symptom severity before and after hysteroscopic correction to determine the effectiveness of this surgical intervention
Participants will be women with uterine malformations who underwent hysteroscopic correction at the Digital Hysteroscopy Center of Policlinico Universitario A Gemelli di Roma and Azienda Ospedaliera Universitaria Federico II di Napoli Data will be retrospectively collected and analyzed to assess the impact of surgery on reproductive 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