Birth Complications and Intrauterine Constraints in the Etiology of Congenital Muscular Torticoll… (NCT06901414) | Clinical Trial Compass
CompletedNot Applicable
Birth Complications and Intrauterine Constraints in the Etiology of Congenital Muscular Torticollis: A Nationwide Registry Study
Norway7,105 participantsStarted 2024-11-26
Plain-language summary
This retrospective register-based cohort study investigates the association between birth complications, intrauterine crowding, and the development of congenital muscular torticollis (CMT). CMT is characterized by the shortening and tightening of the sternocleidomastoid muscle, leading to abnormal head positioning. The study will analyze data from the Norwegian Medical Birth Registry (MFR) and the Norwegian Patient Registry (NPR) to determine whether individuals with CMT have a higher prevalence of birth complications or signs of intrauterine crowding compared to the general population. By identifying risk factors associated with CMT, this study aims to identify the possible etiology of CMT.
Who can participate
Sex
ALL
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:
* Individuals diagnosed with congenital muscular torticollis (ICD-10 code: Q68.0) and registered in the Norwegian Patient Registry (NPR).
* Born in Norway after 1990
* Underwent surgical treatment for CMT (procedure codes NAL39/NAL69/NAL99).
Exclusion Criteria:
* Individuals with incomplete birth registry data in the MFR.
* Presence of congenital anomalies unrelated to CMT that could confound study outcomes.
* Cases with missing gestational age, birth weight, or delivery method.
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
Use of vacuum, forceps extraction
Timeframe: Data from the time period of 1990 to 2023.