Anomaly UterusRUVONCT03052686
Retrospective Study of 110 Cases of Uterine Rupture to Determine Obstetric and Neonatal Complications
An observational study of Anomaly Uterus, run by Hôpital NOVO at 1 site in France.
Trial summary
This study has for objective to collect medical data from patients with uterine rupture at the childbirth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anomaly Uterus
- What is being tested?
- Childbirth with uterine rupture
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2000to Dec 2013
- 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 rupture uterine at the childbirth.
Who may be able to join
- Childbirth with uterine rupture
Who cannot join
- Childbirth in a maternity which do not participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
This study has for objective to collect medical data from patients with uterine rupture at the childbirth.
Read the detailed description
This is a retrospective study, gathering data of five maternity in the department of Val d'Oise in France, during 13 years (between 01/01/2000 an 31/12/2013).
The incidence of uterine rupture increases with increasing cesarean rates. It occurs at a rate of 0.08% across all childbirths in France, and 0.5 to 1% of the childbirths on cicatricial uterus in France.
Although the risk factors are known, it is usually unexpected. This is a serious complication for the mother (mortality <1%, severe morbidity at 15% ) and for the child (mortality for 3 to 6 % for childbirth at term, neonatal asphyxia for 6 to 15%) that can occur during pregnancy or during labor.
- Conditions
- Anomaly Uterus
- Being tested
- Childbirth with uterine rupture
- Keywords
- Uterine rupture
- Medical subject headings
- Uterine Anomalies, Uterine Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childbirth with uterine ruptureOther
No intervention. Follow-up of women with rupture uterine at the childbirth.
| Study group | Role | What they receive |
|---|---|---|
| Childbirth with uterine rupture | No intervention. Follow-up of women with uterine rupture at the childbirth. Receives: Other: Childbirth with uterine rupture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify maternal and foetal risk factors associated to an uterine rupture ; by the report of events during pregnancy, pathology, lifestyle, Concomitant pathology...
Measured: 1 day
Secondary outcomes (1)
Number of maternal and foetal adverse events associated to an uterine rupture at the childbirth.
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 posted14 Feb 2017
- Study startJan 2000
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomaly UterusStudies 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
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARKOU Georges, PH, Principal investigator, CH Rene Dubos, Pontoise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052686
- Sponsor's protocol ID
- CHRD0914
- Acronym
- RUVO
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2016
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of 110 Cases of Uterine Rupture to Determine Obstetric and Neonatal Complications
- ClinicalTrials.gov ID
- NCT03052686
- Acronym / sponsor ID
- RUVO / CHRD0914
- Conditions
- Anomaly Uterus
- Keywords
- Uterine rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Feb 2017 (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.
This study has for objective to collect medical data from patients with uterine rupture at the childbirth.
Detailed description
This is a retrospective study, gathering data of five maternity in the department of Val d'Oise in France, during 13 years (between 01/01/2000 an 31/12/2013).
The incidence of uterine rupture increases with increasing cesarean rates. It occurs at a rate of 0.08% across all childbirths in France, and 0.5 to 1% of the childbirths on cicatricial uterus in France.
Although the risk factors are known, it is usually unexpected. This is a serious complication for the mother (mortality <1%, severe morbidity at 15% ) and for the child (mortality for 3 to 6 % for childbirth at term, neonatal asphyxia for 6 to 15%) that can occur during pregnancy or during labor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Childbirth with uterine rupture | – | Other: Childbirth with uterine ruptureNo intervention. Follow-up of women with uterine rupture at the childbirth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with rupture uterine at the childbirth.
Key inclusion criteria (1 listed)
- Childbirth with uterine rupture
Key exclusion criteria (1 listed)
- Childbirth in a maternity which do not participate to the study
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 |
|---|---|---|
| Childbirth with uterine ruptureNo intervention. Follow-up of women with rupture uterine at the childbirth. | Other | Childbirth with uterine rupture |
Primary outcome
Identify maternal and foetal risk factors associated to an uterine rupture ; by the report of events during pregnancy, pathology, lifestyle, Concomitant pathology...
Time frame: 1 day
1 secondary outcome
Number of maternal and foetal adverse events associated to an uterine rupture at the childbirth.
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 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
MARKOU Georges, PH principal investigator
CH Rene Dubos, Pontoise
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 Anomaly Uterus, run by Hôpital NOVO 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 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: finished, as of the sponsor's last update on 9 Jun 2026. 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?
Identify maternal and foetal risk factors associated to an uterine rupture ; by the report of events during pregnancy, pathology, lifestyle, Concomitant pathology... (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 9 Jun 2026.