Prenatal exposure to zidovudine and risk for ventricular septal defects and congenital heart defects: data from the Antiretroviral Pregnancy Registry.
Vani Vannappagari, Jessica D Albano, Nana Koram...
https://pubmed.ncbi.nlm.nih.gov/26687320Actively Recruiting
Age: 12Years - 60Years
FEMALE
ID00404989
Antiretroviral Pregnancy Registry to Monitor Major Birth Defects from Antiretroviral Drugs During Pregnancy
Led by Syneos Health · Updated on 2025-04-01
24258
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Syneos Health
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.
Who Can Participate
Age: 12Years - 60Years
FEMALE
Eligibility Criteria
You may qualify if you...
- People of childbearing potential
- Documentation that an antiretroviral drug was taken during pregnancy
- Information available to determine if the pregnancy is prospectively or retrospectively registered
- Date when the pregnancy was registered
- Source of the report (patient or healthcare provider)
- Knowledge of whether the pregnancy outcome is known or pending
- Timing of prenatal exposure to the antiretroviral drug within a specific trimester
- Sufficient patient identifier for follow-up
- Whether the patient was involved in a study during prenatal exposure
- Full contact information of the reporter (name, address, etc.)
You will not qualify if you...
- People not exposed to antiretroviral medications during pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm antiretroviral drug exposure during pregnancy and collect initial information
Long-term Monitoring
Duration - Duration of pregnancy plus postnatal period until birth outcomes are known
Participants who have taken antiretroviral drugs during pregnancy are observed to detect any major birth defects.
Follow-up contacts to collect pregnancy outcome information as available
Trial Site Locations
Total: 1 location
1
Registry Coordinating Center
Wilmington, North Carolina, United States, 28403
Actively Recruiting
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Research Team
T
Taylor Cook
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Association between in utero zidovudine exposure and nondefect adverse birth outcomes: analysis of prospectively collected data from the Antiretroviral Pregnancy Registry.
V Vannappagari, N Koram, J Albano...
https://pubmed.ncbi.nlm.nih.gov/26269220