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

NCT06198881 | Unknown

• 1 other identifier: 23-5317
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 3

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.

Conditions

Birth Weight; Macrosomia, Fetal

Keywords

macrosomia; labor induction; perineal tears; hemorrhage; full-term deliveries; singleton

Outcome Measures

Primary Outcomes (1)

• Number of vaginal deliveries among the population studied

  Number of vaginal deliveries among the population studied

  during Delivery

Study Arms (2)

induction of labor

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

Patient presenting with spontaneous labor after 37 weeks of gestation.

Eligibility Criteria

• Age: 12 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The selected patients are thoses who gave birth at term (\>37 weeks) of a macrosome fetus (\>4000g) in one of the maternity wards of the civil hospices of Lyon (Hospital de la Croix Rousse, Hopital Femme Mere Enfant or Hopital Lyon Sud). Patients are subsequently categorized based on whether their labor was induced or not. The characteristics of the pregnancy, the route of delivery and the fetal outcome are then collected in the computerized medical records and analyzed.

You may qualify if:

• Full-term deliveries (≥ 37 weeks of gestation)
• Singleton
• Birth weight \> 4000g
• Complete medical records available for analysis

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hôpital Femme-Mère-Enfant

Bron, 69500, France

Location

Croix Rousse Hospital

Lyon, 69004, France

Location

Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Birth Weight; Fetal Macrosomia; Hemorrhage

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: October 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: January 10, 2024

Record last verified: 2023-12

Locations

FR (3)