Registry for pregnant women with Tuberous Sclerosis Complex and Lymphangioleiomyomatosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.