Uterine Rupture International Data Acquisition

NCT ID: NCT03576950

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-09-30

Brief Summary

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Uterine rupture represents an uncommon event: it is is a life-threatening obstetric complication with high maternal and perinatal morbidity and mortality. Indeed, uterine rupture may cause catastrophic maternal and fetal complications (uterine hemorrhage, hysterectomy with consequent fertility loss, maternal and fetal death or cerebral palsy) which are hardly acceptable within the context of a natural event such as birth.

Uterine rupture can occur during pregnancy, early in labor or following a prolonged labor, most frequently near or at term and, rarely, during early to mid-pregnancy. Its prevalence ranges between 0.006% for women without previous cesarean section (CS) in the western countries, to 25% for women with obstructed labor in African countries.

Pregnancy after myomectomy or CS, vaginal delivery after cesarean sections (VBACs) and vaginal delivery after myomectomy are potentially "at risk" of uterine rupture.

Despite uterine rupture is widely considered a life-threatening condition, so far most of published data refer to case reports or very small case series. In this scenario, the "Uterine Rupture International Data Acquisition" study group would like to collect a large number of events, in order to identify the potential risk factors among different populations through a multivariate analysis.

Detailed Description

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Conditions

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Uterine Rupture Gravid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Uterine rupture

Women with uterine rupture occurred during pregnancy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women with uterine rupture occurred during pregnancy.

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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Antonio Simone Laganà

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Tinelli, M.D.

Role: STUDY_DIRECTOR

U.O. Ginecologia e Ostetricia, Ospedale Vito Fazzi, 73100 Lecce, Italy

Central Contacts

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Andrea Tinelli, M.D.

Role: CONTACT

+393392074078

Other Identifiers

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URIDA

Identifier Type: -

Identifier Source: org_study_id