Registry Study Monitoring Effects of Antiretroviral Drugs During Pregnancy in People Aged 12 to 60

What this Trial Is About

This research aims to monitor any major birth defects caused by antiretroviral drugs taken during pregnancy. The registry collects information from healthcare providers about pregnant people exposed to these drugs to better understand their safety. It is especially important because more people with HIV or hepatitis B are being treated during pregnancy, yet data on the effects of these medications on infants is limited. The registry tracks many antiretroviral medications used during pregnancy, including drugs like abacavir, dolutegravir, efavirenz, and tenofovir, among others. Healthcare providers voluntarily report cases, ideally early in pregnancy, to maximize the accuracy of data collected. Providers may also commit to reporting all antiretroviral exposures at their sites to ensure comprehensive monitoring. Participants provide information through their healthcare providers, who report exposures and pregnancy outcomes to the registry. Follow-up is done after the pregnancy outcome is known. The registry collects details such as timing of drug exposure, pregnancy outcomes, and patient identifiers to allow follow-up. This ongoing data collection helps researchers study the possible risks of antiretroviral drugs during pregnancy over time.

Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.