Registry to monitor the effects of antiretroviral drugs during pregnancy
Antiretroviral Pregnancy Registry
This study is trying to see if certain HIV medications taken during pregnancy can cause any serious problems for the baby.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24258 (estimated) |
| Ages | 12 Years to 60 Years |
| Sex | Female |
| Sponsor | Syneos Health Academic / other |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT00404989 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this registry are pregnant individuals who have been prescribed antiretroviral medications.
Not a fit: Patients who have not been exposed to any of the registry medications during their pregnancy will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide critical insights into the safety of antiretroviral drugs during pregnancy, potentially guiding treatment decisions for pregnant individuals with HIV or Hepatitis B.
How similar studies have performed: Other studies have successfully utilized registries to monitor drug safety during pregnancy, indicating that this approach is both established and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wilmington, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.