CompletedNot Applicable

An Audit of the Posterior Fossa Characterization in Open Spina Bifida Based on Tertiary Center Experience

Belgium316 participantsStarted 2017-04-01

Plain-language summary

Brain stem and posterior fossa measurements in spina bifida aperta fetuses to compare them with normal population. Additionally, Describe the difference between pre- and postoperative findings.

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 were those having fetal MR examination for additional assessment because of the prenatal diagnosis of SBA on ultrasound. * appropriate gestational age - matched controls. The latter were fetuses assessed for other congenital anomalies, which do not affect the central nervous system (CNS) or were scanned for suspected CNS abnormalities with normal prenatal US, fetal MR and normal postnatal evaluation Exclusion Criteria: * twin pregnancy, syndromal pathology, fetal hydrops or anhydramnios. * poor image quality

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) assess the reliability of brain stem and posterior fossa measurements and compare the reliable ones with a normal populations (2) and between paired pre- and postsurgical fetuses

Timeframe: Examinations from 2011 - 2016

Trial details

NCT IDNCT03544970

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-10-26

View on ClinicalTrials.gov More Fetal Anomaly trials

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.