Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorDavid M. Ritter
About this trial
This study is an observational registry designed to gather information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their child.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
This registry is designed to enroll pregnant women who have a TSC and/or LAM diagnosis, a variant of uncertain significance in the TSC 1 or TSC 2 genes, whose fetus has a 50% chance of TSC as deemed by the study PI or Sub-Is, or whose fetus is found to have concern for TSC based on fetal testing. Infants born to an enrolled individual regardless of gender and TSC status are eligible for enrollment into the registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor adherence
Assess number of days participant takes mTOR inhibitor in relation to number of days participant was supposed to take mTOR inhibitor.
Time frame
During pregnancy (up to 40 weeks) through 6 months post-delivery2
Safety of mTOR inhibitor in Pregnancy -- mTOR inhibitor dosing
Review mTOR inhibitor dosing for each participant.
Time frame
During pregnancy (up to 40 weeks) through 6 months post-delivery3
Safety of mTOR inhibitor in Pregnancy -- side effects
Monitor side effects of mTOR inhibitor experienced by participant.
Time frame
During pregnancy (up to 40 weeks) through 6 months post-delivery4
Maternal-Fetal Complications in TSC
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.
Time frame
During pregnancy (up to 40 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
David M. Ritter
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Sponsor institution
Source ClinicalTrials.gov