Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-29 @ 4:43 AM
Study NCT ID:
NCT03576950
Status:
UNKNOWN
Last Update Posted:
2020-11-05
First Post:
2018-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Rupture International Data Acquisition
Sponsor:
Università degli Studi dell'Insubria
Organization:
Study Overview
Official Title:
Uterine Rupture in Pregnancy: the URIDA (Uterine Rupture International Data Acquisition) Study
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
URIDA
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: