Uterine Rupture International Data Acquisition

Uterine Rupture Gravid Clinical Trial

— URIDA  

Official title:

Uterine Rupture in Pregnancy: the URIDA (Uterine Rupture International Data Acquisition) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03576950
• Other study ID #: URIDA
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: September 2023

Study information

• Verified date: November 2020
• Source: Università degli Studi dell'Insubria
• Contact: Andrea Tinelli, M.D.
• Phone: +393392074078
• Email: andreatinelli[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women with uterine rupture occurred during pregnancy.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Rupture
• Uterine Rupture
• Uterine Rupture Gravid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine rupture	Women with uterine rupture occurred during pregnancy.	A retrospective analysis of 10 years.
Secondary	Gestational age at uterine rupture	Gestational age, calculated as weeks and days, in which uterine rupture occurred.	A retrospective analysis of 10 years.
Secondary	Parity	The number of previous delivery.	A retrospective analysis of 10 years.
Secondary	Body Mass Index	The Body Mass Index of each patient in which uterine rupture occurred.	A retrospective analysis of 10 years.
Secondary	Presence of myomas	The occurrence of myomas in each patient in which uterine rupture occurred.	A retrospective analysis of 10 years.
Secondary	Hysterectomy	The number of cases in which it was necessary to perform hysterectomy after uterine rupture.	A retrospective analysis of 10 years.
Secondary	Hospital stay	The hospital stay from the admission to the discharge, expressed in days.	A retrospective analysis of 10 years.
Secondary	Neonatal complications	The occurrence of neonatal complications, included neonatal deaths.	A retrospective analysis of 10 years.