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

December 27, 2023 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hôpital Femme-Mère-Enfant
      • Lyon, France, 69004
        • Croix Rousse Hospital
      • Pierre-Bénite, France, 69495
        • Hôpital Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of vaginal deliveries among the population studied
Time Frame: during Delivery
Number of vaginal deliveries among the population studied
during Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5317

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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