RecruitingNot Applicable

Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)

United States300 participantsStarted 2023-07-01

Plain-language summary

This study is an observational registry designed to gather information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their child.

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: * 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.

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

Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor adherence

Timeframe: During pregnancy (up to 40 weeks) through 6 months post-delivery

Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor dosing

Timeframe: During pregnancy (up to 40 weeks) through 6 months post-delivery

Safety of mTOR inhibitor in Pregnancy -- side effects

Timeframe: During pregnancy (up to 40 weeks) through 6 months post-delivery

Maternal-Fetal Complications in TSC

Timeframe: During pregnancy (up to 40 weeks)

Maternal Post-Partum Behavioral Health

Timeframe: Post-partum up to 6 months

Maternal Post-Partum Mental Health

Timeframe: Post-partum up to 6 months

Optimum Time of Fetal Imaging for TSC

Timeframe: Birth through 5 years of Age

Trial details

NCT IDNCT06160310

SponsorDavid M. Ritter

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-07-01

Contact for this trial

Molly S Griffith, BA

513-636-9669 molly.griffith@cchmc.org

View on ClinicalTrials.gov More Tuberous Sclerosis Complex 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.

What they're measuring

Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor adherence

Timeframe: During pregnancy (up to 40 weeks) through 6 months post-delivery

Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor dosing

Timeframe: During pregnancy (up to 40 weeks) through 6 months post-delivery

Safety of mTOR inhibitor in Pregnancy -- side effects

Timeframe: During pregnancy (up to 40 weeks) through 6 months post-delivery

Maternal-Fetal Complications in TSC

Timeframe: During pregnancy (up to 40 weeks)

Maternal Post-Partum Behavioral Health

Timeframe: Post-partum up to 6 months

Maternal Post-Partum Mental Health

Timeframe: Post-partum up to 6 months

Optimum Time of Fetal Imaging for TSC

Timeframe: Birth through 5 years of Age