Uterine Rupture After Hysteroscopic Septum Resection

April 28, 2021 updated by: Antonio Simone Laganà, Università degli Studi dell'Insubria

Uterine Rupture in Pregnancy After Hysteroscopic Septum Resection: a Twenty-year Retrospective Analysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ljubljana, Italy
        • Antonio Simone Laganà

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 46 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who underwent previous hysteroscopic septum resection.

Description

Inclusion Criteria:

  • Previous hysteroscopic septum resection;
  • Pregnancy;
  • Uterine rupture.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Uterine rupture
Women who had uterine rupture during pregnancy.
Procedure: Hysteroscopic septum resection.
Resection of a uterine septum by hysteroscopic surgery.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Collaborators

University of Ljubljana
Università degli Studi di Brescia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URAHSR-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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