Uterine Rupture GravidURIDANCT03576950
Uterine Rupture International Data Acquisition
An observational study of Uterine Rupture Gravid, run by Università degli Studi dell'Insubria.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Rupture Gravid
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: Women with uterine rupture occurred during pregnancy.
Who may be able to join
- Women with uterine rupture occurred during pregnancy.
Who cannot join
- None.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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
- Keywords
- Uterine rupture, Cesarean section, Labour, Myomectomy, Delivery
- Medical subject headings
- Uterine Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Uterine rupture | Women with uterine rupture occurred during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine rupture
Women with uterine rupture occurred during pregnancy.
Measured: A retrospective analysis of 10 years.
Secondary outcomes (7)
Gestational age at uterine rupture
Gestational age, calculated as weeks and days, in which uterine rupture occurred.
Measured: A retrospective analysis of 10 years.
Parity
The number of previous delivery.
Measured: A retrospective analysis of 10 years.
Body Mass Index
The Body Mass Index of each patient in which uterine rupture occurred.
Measured: A retrospective analysis of 10 years.
Presence of myomas
The occurrence of myomas in each patient in which uterine rupture occurred.
Measured: A retrospective analysis of 10 years.
Hysterectomy
The number of cases in which it was necessary to perform hysterectomy after uterine rupture.
Measured: A retrospective analysis of 10 years.
Hospital stay
The hospital stay from the admission to the discharge, expressed in days.
Measured: A retrospective analysis of 10 years.
Neonatal complications
The occurrence of neonatal complications, included neonatal deaths.
Measured: A retrospective analysis of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Rupture GravidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Andrea Tinelli, M.D., Study director, U.O. Ginecologia e Ostetricia, Ospedale Vito Fazzi, 73100 Lecce, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576950
- Sponsor's protocol ID
- URIDA
- Acronym
- URIDA
- Status last verified
- Nov 2020
- First submitted
- 21 Jun 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Rupture in Pregnancy: the URIDA (Uterine Rupture International Data Acquisition) Study
- ClinicalTrials.gov ID
- NCT03576950
- Acronym / sponsor ID
- URIDA / URIDA
- Conditions
- Uterine Rupture Gravid
- Keywords
- Uterine rupture, Cesarean section, Labour, Myomectomy, Delivery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterine rupture | – | –Women with uterine rupture occurred during pregnancy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with uterine rupture occurred during pregnancy.
Key inclusion criteria (1 listed)
- Women with uterine rupture occurred during pregnancy.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Uterine rupture
Time frame: A retrospective analysis of 10 years.
Women with uterine rupture occurred during pregnancy.
7 secondary outcomes
Gestational age at uterine rupture
Time frame: A retrospective analysis of 10 years.
Parity
Time frame: A retrospective analysis of 10 years.
Body Mass Index
Time frame: A retrospective analysis of 10 years.
Presence of myomas
Time frame: A retrospective analysis of 10 years.
Hysterectomy
Time frame: A retrospective analysis of 10 years.
Hospital stay
Time frame: A retrospective analysis of 10 years.
Neonatal complications
Time frame: A retrospective analysis of 10 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Tinelli, M.D. study director
U.O. Ginecologia e Ostetricia, Ospedale Vito Fazzi, 73100 Lecce, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Rupture Gravid, run by Università degli Studi dell'Insubria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Tinelli, M.D. (+393392074078, andreatinelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine rupture (time frame: A retrospective analysis of 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.