Uterine RuptureNCT04566705
Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery
An observational study of Uterine Rupture and Mode of Delivery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result. Identifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Rupture, Mode of Delivery
- What is being tested?
- Risks factors, maternal and neonatal outcomes/complications
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 Apr 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with uterine rupture after previous cesarean delivery versus women without uterine rupture after previous cesarean delivery
Who may be able to join
- Singleton pregnancy > 24 weeks of gestation
- Second or multiparous with a previous cesarean section without vaginal delivery since
- Cephalic presentation or completed breech
- Uterine rupture during labor
Who cannot join
- Incomplete uterine rupture
- Multiple gestation
- Transverse presentation or complete breech
- Vaginal delivery after cesarean
- Non-low transverse cesarean section
- Placenta praevia
- Antepartum intrauterine fetal death
- History of uterine surgery (myomectomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery : Risks Factors, Maternal and Perinatal Outcomes
Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result.
Identifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the event of attempted vaginal delivery.
The aim of our study is to determine risks factors for uterine rupture during labour in patients with a previous cesarean delivery who have not given birth since and to assess the occurrence of maternal-fetal comply-cations compared to patients with a previous cesarean delivery without uterine rupture.
- Conditions
- Uterine Rupture, Mode of Delivery
- Being tested
- Risks factors, maternal and neonatal outcomes/complications
- Keywords
- Risks factors, Uterine rupture after a previous cesarean delivery, Vaginal birth after cesarean, Prior cesarean, Perinatal outcome
- Medical subject headings
- Uterine Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risks factors, maternal and neonatal outcomes/complicationsOther
Risks factors, maternal and neonatal outcomes/complications
| Study group | Role | What they receive |
|---|---|---|
| Women with uterine rupture | Women with uterine rupture | |
| Women without uterine rupture | Women without uterine rupture Receives: Other: Risks factors, maternal and neonatal outcomes/complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the risks factors of uterine rupture
Assess the risks factors of uterine rupture
Assess the risks factors of uterine rupture using obstetric measures
Measured: 1 day
Secondary outcomes (1)
Number of Participants with Assess the maternal and perinatal complications and outcomes
Number of Participants withAssess the maternal and perinatal complications and outcomes : looking for maternal complications (chorioamnionitis , transfusion, post-partum hemorrhage, surgery for blad-der wound, maternal death,…) and neonatal comply-cations (apgar<7 at 5minutes, pH <7,15, neonatal intein-sive care unit and perinatal death)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Mar 2020
- Primary completion30 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent FUCHS, PUPH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566705
- Sponsor's protocol ID
- RECHMPL20_0142
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery : Risks Factors, Maternal and Perinatal Outcomes
- ClinicalTrials.gov ID
- NCT04566705
- Acronym / sponsor ID
- RECHMPL20_0142
- Conditions
- Uterine Rupture, Mode of Delivery
- Keywords
- Risks factors, Uterine rupture after a previous cesarean delivery, Vaginal birth after cesarean, Prior cesarean, Perinatal outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 28 Sep 2020 (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.
Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result.
Identifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the event of attempted vaginal delivery.
The aim of our study is to determine risks factors for uterine rupture during labour in patients with a previous cesarean delivery who have not given birth since and to assess the occurrence of maternal-fetal comply-cations compared to patients with a previous cesarean delivery without uterine rupture.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with uterine rupture | – | –Women with uterine rupture |
| Women without uterine rupture | – | Other: Risks factors, maternal and neonatal outcomes/complicationsWomen without uterine rupture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with uterine rupture after previous cesarean delivery versus women without uterine rupture after previous cesarean delivery
Key inclusion criteria (4 listed)
- Singleton pregnancy > 24 weeks of gestation
- Second or multiparous with a previous cesarean section without vaginal delivery since
- Cephalic presentation or completed breech
- Uterine rupture during labor
Key exclusion criteria (8 listed)
- Incomplete uterine rupture
- Multiple gestation
- Transverse presentation or complete breech
- Vaginal delivery after cesarean
- Non-low transverse cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risks factors, maternal and neonatal outcomes/complicationsRisks factors, maternal and neonatal outcomes/complications | Other | Women without uterine rupture |
Primary outcome
Assess the risks factors of uterine rupture
Time frame: 1 day
Assess the risks factors of uterine rupture Assess the risks factors of uterine rupture using obstetric measures
1 secondary outcome
Number of Participants with Assess the maternal and perinatal complications and outcomes
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: Undecided. NC
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.
Florent FUCHS, PUPH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Rupture and Mode of Delivery, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the risks factors of uterine rupture (time frame: 1 day). 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 18 Nov 2020.