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NCT06202768 Clinical Trial

Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section

Vaginal Delivery Clinical Trial

— GPP  

Official title:
Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06202768
Other study ID # 2023PI211
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date June 2024

Study information
Verified date April 2024
Source Central Hospital, Nancy, France
Contact Charlotte COTTEZ
Phone 0689677319
Email c.cottez@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 800
Est. completion date June 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Vertex singleton pregnancy - Full-term delivery (beyond 37 weeks) - A history of cesarean section (segmental transverse scar) Exclusion Criteria: - Fetal death in utero

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• data collection
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

Locations
Country Name City State
France Maternity Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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