Uterine Rupture After Hysteroscopic Septum Resection

NCT04449640 — Completed, 3000 participants, Università degli Studi dell'Insubria

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

Registry	NCT04449640
Status	Completed
Study type	Observational
Enrollment	3000 (Actual)
Sponsor	Università degli Studi dell'Insubria (Other); collaborators: University of Ljubljana, Università degli Studi di Brescia
Conditions	Septum; Uterus, Rupture, Uterine
Interventions	Hysteroscopic septum resection. (Procedure)
Dates	start 2020-07-01, primary completion 2021-03-01, completion 2021-04-01, first posted 2020-06-29, last updated 2021-04-29
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Uterine rupture		Procedure: Hysteroscopic septum resection.	Women who had uterine rupture during pregnancy.

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

+Outcome measures

Primary outcomes

Uterine rupture [Retrospective analysis over the last twenty years.]: Rupture of muscular wall of the uterus tears during pregnancy or childbirth.

+Eligibility

Sex: Female, ages: 18 Years to 48 Years

Inclusion Criteria:

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

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Antonio Simone Laganà	Ljubljana	Italy

+Investigators

Antonio Simone Laganà, M.D., Ph.D., Study chair, Università degli Studi dell'Insubria
Helena Ban Frangež, M.D., Ph.D., Study director, University of Ljubljana