Registry to monitor the effects of antiretroviral drugs during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Antiretroviral Pregnancy Registry aims to identify any major teratogenic effects associated with specific antiretroviral medications when administered to pregnant individuals. Participation is voluntary and involves healthcare providers reporting data on pregnant patients who have been exposed to these medications. The registry collects information prospectively, allowing for follow-up on pregnancy outcomes. Providers are encouraged to enroll patients early in their pregnancy to enhance data validity and ensure comprehensive reporting of antiretroviral exposures.

Why it matters

Who can join: the full rules

Eligibility Ages Eligible for Study: People of childbearing potential

Inclusion Criteria:

* Country of origin of report
* Documentation that the registry drug was taken during pregnancy
* Sufficient information to determine if the pregnancy is being prospectively or retrospectively registered
* Date the pregnancy was registered
* Source of report (patient or health care provider)
* Whether the pregnancy outcome is already known or delivery is still pending
* Timing of the prenatal exposure to the registry medication (no broader than which trimester)
* Sufficient patient identifier relevant to reporter to allow for follow-up
* Was patient involved in a study at the time of prenatal exposure
* Full reporter contact information (name, address, etc.)

Exclusion Criteria:

• People who were not exposed to registry medications during pregnancy

Where it's running

• Registry Coordinating Center
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Jessica D Albano, PhD, MPH — Syneos Health
• Study coordinator: Taylor Cook
• Email: SM_APR@APRegistry.com
• Phone: 800-258-4263

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.