Relevance of Ultrasound Screening for Foetal Macrosomia (NCT04443205) | Clinical Trial Compass
UnknownNot Applicable
Relevance of Ultrasound Screening for Foetal Macrosomia
France3,000 participantsStarted 2020-06
Plain-language summary
Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.
Who can participate
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 : Patients (consecutive inclusions) :
Women pregnant Women followed in the gynaecology and obstetrics department of the CHU of Reims, the CHG of Charleville Mézières or the CHG of Chalons en Champagne.
Women for which the delivery is planned in the gynaecology and obstetrics department of the Reims University Hospital, the Charleville Mézières General Hospital or the Chalons en Champagne General Hospital.
Non-inclusion criteria Women without ultrasound dating scan in the first trimester. Women having a contraindication to labour or vaginal delivery Women with a scarred uterus Women having a history of shoulder dystocia or obstetric trauma Women having a history of urinary or fecal incontinence Women having a history of bad birth experience with high psychological impact Women with maternal pathologies (excluding gestational diabetes) Women whose fetus is breech Women with twin pregnancy
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.
1This trial is focused on ultrasound screening for detecting large babies — how accurate is ultrasound at estimating fetal size late in pregnancy, and would participating in this study change how my own measurements are taken or interpreted?
2Since the recruitment status for this trial is listed as unknown, can you find out whether it is still actively enrolling patients before we consider it as an option?
3If this study is observational and just involves ultrasound screenings, does that mean there are no experimental treatments involved, and would my standard prenatal care still continue exactly as normal if I were to participate?
4If my baby is suspected to be large for gestational age, what are the standard monitoring and delivery planning options available to me outside of this trial, so I can compare what extra involvement in the study would actually mean?
5How would the findings from this kind of screening study potentially affect decisions about my delivery method or timing, and is that something my care team would act on during the study or only after results are published?
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.