Relugolix Pregnancy Registry: Safety in Pregnant Women and Their Babies
This is an observational study, called the Relugolix Pregnancy Registry, looking at the safety of relugolix-containing medicines when taken during pregnancy. Researchers want to understand if there's a connection between taking relugolix and any health outcomes for the mother, fetus, or baby. You can join if you are a woman of any age who is currently or recently pregnant and agree to participate. The main goal is to see if relugolix is linked to major birth defects (major congenital malformation). This study is currently unclear on its recruitment status.
- Study design
- This is an observational study designed to enroll 728 women. There are two groups: those exposed to relugolix during pregnancy and those with a condition that might be treated with relugolix but who were not exposed.
- What's involved
- You would provide consent and authorize your healthcare providers to share your medical data with the registry. No additional tests or doctor visits are required beyond your usual medical care.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pregnancy outcomes will be assessed throughout pregnancy, and infant outcomes will be assessed for the first year of life. The primary outcome, major congenital malformation, will be measured for up to 10 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Major Congenital Malformation (MCM)Up to 10 years
Comparison of rate of MCM between cohorts