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

Civil Hospices of Lyon

Status: Active, not recruiting

Conditions: Birth Weight; Macrosomia, Fetal

Study type: Observational

Funder types: Other

Identifiers

NCT06198881

23-5317

Details and patient eligibility

About

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.

Enrollment: 4,500 estimated patients

Sex: Female

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

4,500 participants in 2 patient groups

induction of labor

Description:

Patient having been induced by cervical ripening (prostin gel (2mg/24h), intravaginal prostaglandin (10mg/24h), balloon (\<12h exposure time) or oral misoprostole (50µg/4h until induction of labor) or induction of contractions by oxytocin (gradual increase in dose) for suspected ultrasound macrosomia (according to the criteria of the DAME study)

natural labor

Description:

Patient presenting with spontaneous labor after 37 weeks of gestation.