Uterine Rupture International Data Acquisition

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03576950

Acronym

URIDA

Enrollment

100

Registered

2018-07-05

Start date

2021-09-30

Completion date

2023-09-30

Last updated

2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Rupture Gravid

Keywords

Uterine rupture, Cesarean section, Labour, Myomectomy, Delivery

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Inclusion criteria

* Women with uterine rupture occurred during pregnancy.

Exclusion criteria

* None.

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactAndrea Tinelli, M.D.

andreatinelli@gmail.com+393392074078

Outcome results