Vaginal DeliveryGPPNCT06202768
Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section
An observational study of Vaginal Delivery, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The rate of pregnant patients with a history of cesarean section is increasing. Caesarean section is a surgery which is not without risk and in particular concerning the risk of uterine rupture and malplacentation during a new pregnancy. Considering the outcome of a new birth following a cesarean section is not easy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vaginal Delivery
- What is being tested?
- data collection
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to Jun 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population of women who gave birth at the Nancy maternity ward and met the inclusion criteria, from January 2014 to January 2021.
Who may be able to join
- Vertex singleton pregnancy
- Full-term delivery (beyond 37 weeks)
- A history of cesarean section (segmental transverse scar)
Who cannot join
- Fetal death in utero
Trial locations and contacts
1 site in 1 country.
France1 site
Maternity
Nancy
BELLOCHIO, melanie.bellochio@yahoo.fr
COTTEZ, c.cottez@chru-nancy.fr
About this study
The rate of pregnant patients with a history of cesarean section is increasing. Caesarean section is a surgery which is not without risk and in particular concerning the risk of uterine rupture and malplacentation during a new pregnancy.
Considering the outcome of a new birth following a cesarean section is not easy. There is no reliable score to predict the success rate of vaginal delivery with a history of scarred uterus. The aim of our study would be to validate the intrapartum Grobman nomogram within the population of the Nancy University Hospital and thus to target the population for whom vaginal delivery could be offered.
- Conditions
- Vaginal Delivery
- Being tested
- data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data collection : age, gestational age, BMI, history of vaginal delivery after cesarean section, indication for cesarean section, preeclampsia for this pregnancy, the cervix dilatation, position in the pelvis, cervix consistency
| Study group | Role | What they receive |
|---|---|---|
| Main population | History of cesarean section Vertex singleton gestation At term (at least 37 weeks of gestation) Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Grobman score
calculate Grobman score according to different criteria. If the score is high, the probability of vaginal delivery is high. This a score which calculates probability of vaginal delivery thanks to 11 parameters (maternal âge, BMI, previous vaginal delivery before and after ceasection, recurring indication, gestational age, hypertensive disease of pregnancy, effacement, dilatation, foetal station, labor induction)
Measured: per-partum, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, COTTEZ Charlotte, Central Hospital, Nancy, France
- Investigators
- Charlotte COTTEZ, Study director, Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202768
- Sponsor's protocol ID
- 2023PI211
- Acronym
- GPP
- Status last verified
- Apr 2024
- First submitted
- 1 Jan 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section
- ClinicalTrials.gov ID
- NCT06202768
- Acronym / sponsor ID
- GPP / 2023PI211
- Conditions
- Vaginal Delivery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
The rate of pregnant patients with a history of cesarean section is increasing. Caesarean section is a surgery which is not without risk and in particular concerning the risk of uterine rupture and malplacentation during a new pregnancy.
Considering the outcome of a new birth following a cesarean section is not easy. There is no reliable score to predict the success rate of vaginal delivery with a history of scarred uterus. The aim of our study would be to validate the intrapartum Grobman nomogram within the population of the Nancy University Hospital and thus to target the population for whom vaginal delivery could be offered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main population | – | Other: data collectionHistory of cesarean section Vertex singleton gestation At term (at least 37 weeks of gestation) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population of women who gave birth at the Nancy maternity ward and met the inclusion criteria, from January 2014 to January 2021.
Key inclusion criteria (3 listed)
- Vertex singleton pregnancy
- Full-term delivery (beyond 37 weeks)
- A history of cesarean section (segmental transverse scar)
Key exclusion criteria (1 listed)
- Fetal death in utero
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 |
|---|---|---|
| data collectiondata collection : age, gestational age, BMI, history of vaginal delivery after cesarean section, indication for cesarean section, preeclampsia for this pregnancy, the cervix dilatation, position in the pelvis, cervix consistency | Other | Main population |
Primary outcome
Modified Grobman score
Time frame: per-partum, 9 months
calculate Grobman score according to different criteria. If the score is high, the probability of vaginal delivery is high. This a score which calculates probability of vaginal delivery thanks to 11 parameters (maternal âge, BMI, previous vaginal delivery before and after ceasection, recurring indication, gestational age, hypertensive disease of pregnancy, effacement, dilatation, foetal station, labor induction)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
Charlotte COTTEZ study director
Hospital, Nancy, France
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 Vaginal Delivery, run by Central Hospital, Nancy, France 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 3 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 17 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte COTTEZ (0689677319, c.cottez@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Grobman score (time frame: per-partum, 9 months). 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 17 Apr 2024.