Uterine Rupture After Hysteroscopic Septum Resection

Septum; Uterus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449640
• Other study ID #: URAHSR-1
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Rupture
• Rupture, Uterine
• Septum; Uterus
• Uterine Rupture

Intervention

Procedure:
• Hysteroscopic septum resection.
Resection of a uterine septum by hysteroscopic surgery.

Locations

Country	Name	City	State
Italy	Antonio Simone Laganà	Ljubljana

Sponsors (3)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria	Università degli Studi di Brescia, University of Ljubljana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine rupture	Rupture of muscular wall of the uterus tears during pregnancy or childbirth.	Retrospective analysis over the last twenty years.