Uterine Rupture After Hysteroscopic Septum Resection

Completed

• Conditions: Rupture, Uterine; Septum; Uterus
• Interventions: Procedure: Hysteroscopic septum resection.

• Registration Number: NCT04449640
• Lead Sponsor: Università degli Studi dell'Insubria

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 available

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-29
• Study Start: 2020-07-01
• Primary Completion: 2021-03-01
• Status Verified: 2021-04
• Study Completion: 2021-04-01
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uterine rupture	Hysteroscopic septum resection.	Women who had uterine rupture during pregnancy.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Antonio Simone Laganà; 🇮🇹 Ljubljana, Italy