NCT06202768

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

January 1, 2024

Last Update Submit

April 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    per-partum, 9 months

Study Arms (1)

Main population

History of cesarean section Vertex singleton gestation At term (at least 37 weeks of gestation)

Other: data collection

Interventions

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

Main population

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population of women who gave birth at the Nancy maternity ward and met the inclusion criteria, from January 2014 to January 2021.

You may qualify if:

  • Vertex singleton pregnancy
  • Full-term delivery (beyond 37 weeks)
  • A history of cesarean section (segmental transverse scar)

You may not qualify if:

  • Fetal death in utero

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity

Nancy, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Charlotte COTTEZ

    Hospital, Nancy, France

    STUDY DIRECTOR

Central Study Contacts

Charlotte COTTEZ

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post-resident

Study Record Dates

First Submitted

January 1, 2024

First Posted

January 12, 2024

Study Start

May 1, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations