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Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry

This observational registry aims to collect information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their children. The study is looking at the safety of mTOR inhibitors (a type of medication that targets the mTOR pathway, which is overactive in TSC) during pregnancy, including how well women stick to their medication, the doses they take, and any side effects. You may be able to join if you are pregnant and have a diagnosis of TSC or LAM, or if your fetus has a high chance of having TSC. The study hopes to enroll 300 participants to help doctors create better guidelines for care during pregnancy and screening for TSC in babies.

Study design
This is an observational registry, meaning researchers will collect information without giving any specific treatments. The study plans to enroll 300 participants.
What's involved
You will be asked to complete monthly online surveys about your pregnancy, health, and medications. For infants, clinical data will be collected and reviewed for up to 5 years after birth.
Compensation
Not stated in the trial record.
Follow-up
Information on mTOR inhibitor adherence, dosing, and side effects will be collected during pregnancy (up to 40 weeks) through 6 months post-delivery. For infants, clinical data will be collected for up to 5 years of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06160310

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

Recruiting
Not specifiedAll AgesObservational
David M. Ritter
~300 participants
Updated 2026-01-23 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor adherence
Measured over During pregnancy (up to 40 weeks) through 6 months post-delivery
+6 more outcomes measured

Conditions

Tuberous Sclerosis Complex
Lymphangioleiomyomatosis

Explore related trials

LymphangioleiomyomatosisTuberous SclerosisHamartinTSC2 Gene

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • David M Ritter, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Molly S Griffith, BA
[email protected]
513-636-9669
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Infants diagnosed with TSC whose birth mother was not enrolled.

What this trial measures

  • Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor adherenceDuring pregnancy (up to 40 weeks) through 6 months post-delivery

    Assess number of days participant takes mTOR inhibitor in relation to number of days participant was supposed to take mTOR inhibitor.

  • Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor dosingDuring pregnancy (up to 40 weeks) through 6 months post-delivery

    Review mTOR inhibitor dosing for each participant.

  • Safety of mTOR inhibitor in Pregnancy -- side effectsDuring pregnancy (up to 40 weeks) through 6 months post-delivery

    Monitor side effects of mTOR inhibitor experienced by participant.

  • Maternal-Fetal Complications in TSCDuring pregnancy (up to 40 weeks)

    Screening for changes in pregnancy, maternal health/medication changes and other care by using a study-developed monthly questionnaire inquiring about pregnancy status, maternal and/or fetal testing, changes to maternal and fetal care clinical providers, addition or removal of medications, changes in medication doses, and addition of new complications to mother and/or fetus using a list of common gestational complications within prior month.

  • Maternal Post-Partum Behavioral HealthPost-partum up to 6 months

    Participant will complete Tuberous Sclerosis Complex associated Neuropsychiatric Disorders (TAND) questionnaire.

  • Maternal Post-Partum Mental HealthPost-partum up to 6 months

    Participant will complete the Edinburgh Postnatal Depression Scale (EPDS).

  • Optimum Time of Fetal Imaging for TSCBirth through 5 years of Age

    Compare fetal imaging to imaging and clinical data including echocardiograms, electrocardiograms, genetic testing results, magnetic resonance images of the brain and abdomen, ultrasounds.