Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant Women. (APR)
Antiretroviral Pregnancy Registry
The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major teratogenic effect involving any of the Registry drugs when administered to pregnant women. Registration is voluntary and confidential with information obtained from the health care provider. A Registry-assigned identifier allows for follow-up capability. Information on subjects is provided to the Registry prospectively (prior to the outcome of pregnancy being known) through their health care provider, with follow-up obtained from the health care provider after the outcome is determined. Providers are strongly urged to enroll their patients as early in pregnancy as possible to maximize the validity of the data. In addition, the Registry is very interested in assembling a group of providers who are willing to make a commitment to report all of their site's antiretroviral pregnancy exposures to the Registry, thereby assuring all cases can be considered prospective. Providers are encouraged to contact the Registry for more information about this group. The Registry is informed in its analysis by other data, for example, retrospective reports and clinical studies.
Given the increasing number of medications and more aggressive approach to therapy, more HIV- and hepatitis B-infected women may be treated during pregnancy or become pregnant while under treatment. The paucity of data on use and infant outcomes of antiretroviral therapies during pregnancy makes this Registry an essential component of the ongoing program of epidemiologic studies of the safety of these therapies.
Each year the Registry has enrolled approximately 1300-1700 pregnant women in the US exposed to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive women who give birth to live infants annually in the US.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Taylor Cook
- Phone Number: 800-258-4263
- Email: SM_APR@APRegistry.com
Study Locations
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North Carolina
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Wilmington, North Carolina, United States, 28403
- Recruiting
- Registry Coordinating Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Eligibility Ages Eligible for Study: Women of childbearing age
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:
- Females who were not exposed to registry medications during pregnancy
- Male patients
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jessica D Albano, PhD, MPH, Syneos Health
Publications and helpful links
General Publications
- Vannappagari V, Albano JD, Koram N, Tilson H, Scheuerle AE, Napier MD. Prenatal exposure to zidovudine and risk for ventricular septal defects and congenital heart defects: data from the Antiretroviral Pregnancy Registry. Eur J Obstet Gynecol Reprod Biol. 2016 Feb;197:6-10. doi: 10.1016/j.ejogrb.2015.11.015. Epub 2015 Nov 24.
- Vannappagari V, Koram N, Albano J, Tilson H, Gee C. Association between in utero zidovudine exposure and nondefect adverse birth outcomes: analysis of prospectively collected data from the Antiretroviral Pregnancy Registry. BJOG. 2016 May;123(6):910-6. doi: 10.1111/1471-0528.13542. Epub 2015 Aug 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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