Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA … (NCT06198881) | Clinical Trial Compass
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Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study
France4,500 participantsStarted 2023-10-01
Plain-language 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.
Who can participate
Age range
12 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of vaginal deliveries among the population studied