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NCT06198881 Clinical Trial

Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study

Birth Weight Clinical Trial

— MACROMODA  

Official title:
Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06198881
Other study ID # 23-5317
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date January 1, 2024

Study information
Verified date December 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The rising prevalence fof fetal macrosomia represents a significant challenge in obstetrics, affecting both maternal and neonatal outcomes. Such challenges include complications like perineal tears and postpartum hemorrhage. Concurrently, the frequency of labor induction practices on the rise, yet the implications for neonatal weight are inadequately understood. To address this gap, our study aims to evaluate the association between labor induction and neontal birth weight through a population-based cohort study. The findings have the potential to inform more accurate clinical guidelines, thereby enhancing the quality of maternity care.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4500
Est. completion date January 1, 2024
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 12 Years to 50 Years
Eligibility Inclusion Criteria: - Full-term deliveries (= 37 weeks of gestation) - Singleton - Birth weight > 4000g - Complete medical records available for analysis Exclusion Criteria: - Delivery < 37 weeks - Uterus > bi-scarred - Presentation of the headquarters - Maternal or fetal pathology modifying the route/time of delivery (pre-eclampsia, fetal heart rate abnormalities, cholestasis, chorioamnionitis, metrorrhagia, covering placenta, etc.)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Hôpital Femme-Mère-Enfant Bron
France Croix Rousse Hospital Lyon
France Hôpital Lyon Sud Pierre-Bénite

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of vaginal deliveries among the population studied Number of vaginal deliveries among the population studied during Delivery
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