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Uterine Rupture International Data Acquisition

NCT03576950 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-11-05

No results posted yet for this study

Summary

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.

Conditions

  • Uterine Rupture Gravid

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    lead OTHER

Principal Investigators

  • Andrea Tinelli, M.D. · U.O. Ginecologia e Ostetricia, Ospedale Vito Fazzi, 73100 Lecce, Italy

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-09-30
Completion
2023-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576950 on ClinicalTrials.gov