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Congenital Muscular TorticollisNCT06901414

Birth Complications and Intrauterine Constraints in the Etiology of Congenital Muscular Torticollis: A Nationwide Registry Study

An observational study of Congenital Muscular Torticollis, run by Vestre Viken Hospital Trust at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Congenital Muscular Torticollis
How many people
7,105 participants
Where
1 siteNorway
Study dates
26 Nov 2024to 26 Nov 2024
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The study will include a cohort of individuals diagnosed with congenital muscular torticollis (CMT) who have been diagnosed and/or undergone surgical treatment in Norway during the time period of 1990 to 2023. These cases will be identified from the Norwegian Patient Registry (NPR) based on diagnosis and procedure codes. The control group will consist of individuals from the general population, matched in a 1:4 ratio based on birth year, sex, and gestational age at birth. The study will analyze perinatal and birth-related factors, such as mode of delivery, signs of birth trauma, and intrauterine conditions, using data from the Norwegian Medical Birth Registry (MFR).

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Vestre Viken HF

    Drammen, 3004

Other trials in Norway

About this study

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.

Read the detailed description

Congenital Muscular Torticollis (CMT) is a condition affecting infants, characterized by a shortened and tightened sternocleidomastoid muscle (SCM), resulting in abnormal head positioning. Despite various theories, the exact etiology of CMT remains unclear. Two primary hypotheses include birth trauma and intrauterine crowding. Some studies have suggested an association between CMT and operative deliveries, whereas others have found no such association. Similarly, intrauterine crowding, such as in multiple pregnancies, has been proposed as a contributing factor due to mechanisms like ischemia or compartment syndrome.

While most children with CMT experience a mild condition that resolves with stretching and physiotherapy, a notable overrepresentation of complicated deliveries has been observed among patients requiring surgical intervention for CMT. This study aims to further explore these hypotheses by analyzing data from the Norwegian Medical Birth Registry (MFR).

Study Objectives The primary objective of this study is to compare the prevalence of operative deliveries and indicators of intrauterine crowding between individuals diagnosed with CMT and the general population. The study seeks to determine whether complicated deliveries and/or crowding are overrepresented among patients with CMT. Specifically, the study will investigate whether there is an increased occurrence of restricted intrauterine conditions or operative deliveries in CMT patients compared to the general birth cohort. If a significant association is found, it would support the hypothesis that these factors contribute to the development of CMT.

Expected Outcomes By conducting this study, we expect to contribute to a better understanding of the potential causes of CMT. The findings may improve early identification and potentially influence obstetric and neonatal management strategies.

Methods This is a registry-based study utilizing anonymized data from the Norwegian Patient Registry (NPR) and linking it to the MFR. The study will identify a cohort of individuals diagnosed with CMT and a matched control group (1:4) from the general population.

Study Design Type: Retrospective, cohort, observational, registry-based study. Matching: Cases will be matched with controls based on birth year, sex, and gestational age at birth in a 1:4 ratio.

Population: Patients diagnosed with CMT who have undergone surgery in Norway, born between 1990 and 2023, will be identified using ICD-10 code Q68.0 and procedure codes NAL39/NAL69/NAL99.

Variables

The study will collect data on variables relevant to birth trauma and crowding hypotheses:

Birth Trauma Indicators:

  • Mode of delivery (spontaneous vaginal delivery, assisted vaginal delivery, cesarean section)
  • Shoulder dystocia indicators (clavicle fracture, brachial plexus injury)
  • Birth weight (>4000g, macrosomia)
  • Breech presentation (vaginal delivery)
  • Vacuum-assisted delivery
  • Forceps-assisted delivery
  • Emergency cesarean section due to mechanical complications
  • Indications for cesarean section (maternal or fetal factors)

Crowding Indicators:

  • Multiple pregnancies (number of fetuses per pregnancy)
  • Amniotic fluid levels (normal vs. polyhydramnios)
  • Fetal position at birth (cephalic, breech, transverse)
  • Birth weight and length relative to gestational age
  • Gestational duration (preterm, full-term, post-term)
  • Maternal height
  • Birth order (firstborn vs. later-born)

Data Collection Data will be retrieved from MFR and NPR through Helsedata.no. The collected data will be anonymized to ensure compliance with ethical guidelines.

Statistical Analysis

The study will employ appropriate statistical methods to compare the prevalence of the examined variables between the CMT cohort and the control group:

  • Descriptive statistics to summarize demographic and clinical variables.
  • Univariate analysis (Chi-square or Fisher's exact test) to compare the frequency of complicated deliveries between groups.
  • Multivariate logistic regression analysis to adjust for confounding variables, including maternal age, comorbidities, gestational age, birth weight, and delivery method.
  • Directed Acyclic Graphs (DAGs) will be utilized to illustrate causal relationships.

Limitations

  • Potential limitations in available data from MFR.
  • Retrospective study design with possible missing or incomplete data.
  • The need to differentiate between the causality of crowding and operative delivery, as crowding may necessitate operative delivery.
  • Variability in delivery methods across hospitals.
  • Selection bias in operative deliveries due to pre-existing intrauterine conditions.

Ethical Considerations Ethical approval will be obtained from the Regional Committees for Medical and Health Research Ethics (REK) and the local privacy protection officer (PVO) at Vestre Viken. The study will use de-identified registry data to maintain participant confidentiality. There will be no direct patient involvement, ensuring compliance with ethical standards.

This study is expected to provide significant insights into the etiology of CMT, contributing to better prevention and management strategies for affected individuals.

Keywords
Congenital muscular torticollis, Birth trauma, crowding, etiology, birth registry
Medical subject headings
Congenital torticollis, Birth Injuries, Crowding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06901414
Study groupRoleWhat they receive
CMT casesChildren identified in the Norwegian Patient Registry (NPR) with the diagnosis of congenital muscular torticollis (ICD-10 Q68.0) born between 1990 and 2023
Matched control groupConsisting of individuals from the general population, matched in a 1:4 ratio based on birth year, sex, and gestational age at birth.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Use of vacuum, forceps extraction

    The use of vacuum extraction or forceps (operative deliveries), indicates birth complications. It has been hypothesized that such operative deliveries are associated with an increased incidence of congenital muscular torticollis.

    These variables are consistently registered in the Norwegian Birth Registry and have been made accessible to us from the Norwegian Helsedata.no registers.

    Measured: Data from the time period of 1990 to 2023.

Secondary outcomes (7)
  1. Caesarean section

    Caesarean sections will be indentified and compared within groups. One hypothesis is that a caeserian section can protect against CMT by avoiding a possible birth trauma. These variables are consistently registered in the Norwegian Birth Registry and have been made accessible to us from the Norwegian Helsedata.no registers.

    Measured: 1990-2023

  2. Breech position

    Breech position is possibly associated with both crowding and birth trauma. This variable is consistently registered in the Norwegian Birth Registry and have been made accessible to us from the Norwegian Helsedata.no registers.

    Measured: 1990-2023

  3. Clavicle fracture

    Clavicle fractures may indicate a birth trauma. These variables are consistently registered in the Norwegian Birth Registry and have been made accessible to us from the Norwegian Helsedata.no registers.

    Measured: 1990-2023

  4. Macrosomic infants

    Birth weight is routinely registered, with a particular focus on macrosomic infants (>4,000 g birth weight), as it has been hypothesized that macrosomic infants carries a larger risk for CMT (due to the increased risk for a birth trauma).

    This variable is consistently registered in the Norwegian Birth Registry and have been made accessible to us from the Norwegian Helsedata.no registers.

    Measured: 1990-2023

  5. Multiple gestations

    Multiple gestations, such as twins or higher-order pregnancies, indicate possible crowding. This variable is consistently registered in the Norwegian Birth Registry and have been made accessible to us from the Norwegian Helsedata.no registers.

    Measured: 1990-2023

  6. Amniotic fluid levels

    Amniotic fluid levels (oligohydramnion/polyhydramnion) may indicate crowding. Crowding har been associated with a higher risk of CMT, causing (possibly) a compartment syndrome within the sternocleid muscles. This variable is consistently registered in the Norwegian Birth Registry and have been made accessible to us from the Norwegian Helsedata.no registers.

    Measured: 1990-2023

  7. Maternal height

    Maternal height may be associated with increased risk of both crowding and birth complications. This variable is consistently registered in the Norwegian Birth Registry and have been made accessible to us from the Norwegian Helsedata.no registers.

    Measured: 1990-2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2025
  2. Study start26 Nov 2024
  3. Primary completion26 Nov 2024
  4. Study completion26 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
7,105 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06901414
Sponsor's protocol ID
CMT Etiology
Status last verified
Mar 2025
First submitted
22 Mar 2025
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Despite the fact that our data are non-identifiable, the permission granted us by the Regional Ethics Committee does not allow us to share data outside our study group.

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Muscular Torticollis, run by Vestre Viken Hospital Trust at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Use of vacuum, forceps extraction (time frame: Data from the time period of 1990 to 2023.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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