Uterine Rupture International Data Acquisition (URIDA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Uterine Rupture Gravid

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Andrea Tinelli, M.D.; Phone Number: +393392074078; Email: andreatinelli@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with uterine rupture occurred during pregnancy.

Description

Inclusion Criteria:

• Women with uterine rupture occurred during pregnancy.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Uterine rupture; Women with uterine rupture occurred during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine rupture	Women with uterine rupture occurred during pregnancy.	A retrospective analysis of 10 years.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Study Director: Andrea Tinelli, M.D., U.O. Ginecologia e Ostetricia, Ospedale Vito Fazzi, 73100 Lecce, Italy

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (ACTUAL): July 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Cesarean section; Delivery; Myomectomy; Labour; Uterine rupture
• Additional Relevant MeSH Terms: Uterine Diseases; Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Rupture; Uterine Rupture
• Other Study ID Numbers: URIDA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No