NCT04449640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

June 24, 2020

Last Update Submit

April 28, 2021

Conditions

Septum; UterusRupture, Uterine

Keywords

HysteroscopyUterine septumComplicationsUterine perforationPregnancyUterine rupture

Outcome Measures

Primary Outcomes (1)

  • Uterine rupture

    Rupture of muscular wall of the uterus tears during pregnancy or childbirth.

    Retrospective analysis over the last twenty years.

Study Arms (1)

Uterine rupture

Women who had uterine rupture during pregnancy.

Procedure: Hysteroscopic septum resection.

Interventions

Hysteroscopic septum resection.PROCEDURE

Resection of a uterine septum by hysteroscopic surgery.

Uterine rupture

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women who underwent previous hysteroscopic septum resection.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio Simone Laganà

Ljubljana, Italy

Location

MeSH Terms

Conditions

Uterine RuptureSeptate UterusUterine Perforation

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor ComplicationsPregnancy ComplicationsGenital DiseasesRuptureWounds and InjuriesUterine Duplication Anomalies

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 29, 2020

Study Start

July 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

IT(1)