Uterine Rupture After Hysteroscopic Septum Resection | NCT04449640

Studies
Uterine Rupture After Hysteroscopic Septum Resection

NCT04449640

Sponsor

Università degli Studi dell'Insubria

Status

Completed

Last Update Posted

Apr 29, 2021Actual

Enrollment

3,000Actual

Phase

Not provided

Conditions

Septum; Uterus
Rupture, Uterine

Interventions

Hysteroscopic septum resection.

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

Jun 24, 2020

First Submission Date that Met QC Criteria

Jun 24, 2020

First Posted Date

Jun 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2021

Last Update Posted Date

Apr 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'InsubriaPrincipal Investigator

Lead Sponsor

Università degli Studi dell'InsubriaOTHER

Collaborators

Name	Class
University of Ljubljana	OTHER
Università degli Studi di Brescia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To date, several studies have already confirmed a positive effect of hysteroscopic metroplasty on reproductive outcomes in primary infertile women affected by uterine septum, the most common uterine malformation. Nevertheless, very few data are available about the risk of uterine rupture in subsequent pregnancies after hysteroscopic septum resection (HSR). In order to shed about this element, we will retrospectively review the cases of uterine rupture in our setting in the last twenty years, identify which of them had previously undergone HSR, and evaluate the main clinical characteristics for each case.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Uterine rupture		Women who had uterine rupture during pregnancy.	Procedure: Hysteroscopic septum resection.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hysteroscopic septum resection.	Procedure	Resection of a uterine septum by hysteroscopic surgery.	Uterine rupture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uterine rupture	Rupture of muscular wall of the uterus tears during pregnancy or childbirth.	Retrospective analysis over the last twenty years.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previous hysteroscopic septum resection;
Pregnancy;
Uterine rupture.

Exclusion Criteria:

Previous myomectomy (regardless of the surgical technique) or cesarean section.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Pregnant women who underwent previous hysteroscopic septum resection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antonio Simone Laganà, M.D., Ph.D.	Università degli Studi dell'Insubria	Study Chair
Helena Ban Frangež, M.D., Ph.D.	University of Ljubljana	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antonio Simone Laganà		Ljubljana			Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014597	Uterine Rupture
D000093665	Septate Uterus
D014595	Uterine Perforation

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided