Registry for pregnant women with Tuberous Sclerosis Complex and Lymphangioleiomyomatosis
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry
This study is collecting information from pregnant women with Tuberous Sclerosis Complex and Lymphangioleiomyomatosis to see how their health and their babies' health are affected during pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | Female |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06160310 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect data on pregnant women diagnosed with Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM), focusing on their health and the health of their infants. Participants will complete monthly online surveys to monitor changes in pregnancy, maternal health, and medication use. The study seeks to develop evidence-based guidelines for managing TSC and LAM during pregnancy and to provide recommendations for screening infants for TSC. Clinical data will also be collected for infants up to five years of age.
Who should consider this trial
Good fit: Ideal candidates include pregnant women with a clinical or genetic diagnosis of TSC or LAM, as well as those with specific genetic variants or fetal concerns related to TSC.
Not a fit: Patients who do not have TSC or LAM and do not meet specific inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could lead to improved care and management strategies for pregnant women with TSC and LAM, enhancing outcomes for both mothers and their children.
How similar studies have performed: While observational registries for similar conditions exist, this specific focus on pregnancy in TSC and LAM is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A pregnant woman with a clinical or genetic diagnosis of TSC as determined by the 2021 Consensus Guidelines (1) * A pregnant woman with a diagnosis of LAM * A pregnant woman with a variant of uncertain significance in TSC 1 or TSC 2 * A pregnant woman who is pregnant and the fetus has a 50% chance of TSC as deemed by the PI or Sub-Is * A pregnant woman whose fetus is found to have concern for TSC secondary to rhabdomyomas, tubers, or congenital subependymal giant cell astrocytoma. * An infant born to an enrolled individual. Exclusion Criteria: * A pregnant woman without TSC who has used preimplantation genetic testing for TSC unless qualifies under inclusion criteria #4. * Infants diagnosed with TSC whose birth mother was not enrolled.
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David M Ritter, MD, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Molly S Griffith, BA
- Email: molly.griffith@cchmc.org
- Phone: 513-636-9669
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.