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Clinical Trials/NCT06198881
NCT06198881
Active, not recruiting
Not Applicable

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

Hospices Civils de Lyon3 sites in 1 country4,500 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Birth Weight
Sponsor
Hospices Civils de Lyon
Enrollment
4500
Locations
3
Primary Endpoint
Number of vaginal deliveries among the population studied
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
January 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

Number of vaginal deliveries among the population studied

Time Frame: during Delivery

Number of vaginal deliveries among the population studied

Study Sites (3)

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