Antiretroviral
Pregnancy Registry |
 |
What
is the Registry? |
|
|
Why
is the Registry important? |
|
|
How
to participate in the Registry |
|
|
How
are the data collected by the Registry analyzed and reported? |
|
|
How
does participation benefit me and my patients? |
|
|
How
can I get more information? |
| The
success of the Registry depends on the continued participation of
health-care providers who register patients and assist in
providing follow-up information postpartum. |
|
|
|
What
is the Registry?
The
Antiretroviral Pregnancy Registry is intended to provide an early
signal of any major teratogenic effect associated with a prenatal
exposure to the products monitored through the Registry. The
Registry is a voluntary prospective, exposure-registration,
observational study designed to collect and evaluate data on the
outcomes of pregnancy exposures to antiretroviral products.
An
Advisory Committee was established to review data and establish a
consensus regarding results of the data at that time and makes
recommendations on data collected and on issues arising during the
conduct of the Registry. The Committee also encourages referral of
reports to the Registry and
disseminates Registry information. The Advisory Committee with
representatives from the Sponsor companies comprise the Registry
Steering Committee. The Steering Committee meets semi-annually to
discuss issues, review data, update the interim report published
following each meeting, and to discuss the general conduct of the
Registry.
Assuring
patient confidentiality is a very high priority for the Registry,
for this reason no patient identifiers are collected. The Registry has sought and obtained IRB
(institutional review board) approval. With the IRB approval of
the protocol, the Registry was granted a waiver from obtaining
patient informed consent. Additionally, the Registry reviews data
privacy issues related to the information it processes on a regular basis.
back
to the top
|
|
Why
is the Registry important?
This
Registry is the only project expressly established to evaluate
first trimester, as well as later prenatal exposures to
antiretroviral medications. Registry data supplement other sources
of data and assist clinicians and patients in weighing potential
risks and benefits of treatment.
There
are
completed and ongoing clinical trials of several antiretrovirals in pregnant women.
However, the manufacturers of these
antiretroviral products recognize the need to continuously monitor
the safety of their products, particularly for rare events that
are difficult to identify in small populations.
back
to the top
|
|
How
to participate in the Registry
Health-care
providers are asked to prospectively (before outcome of
pregnancy is known) register women who have been exposed during
pregnancy to the medications followed in the Registry. Patient
confidentiality is strictly guarded, with no
identifying patient information collected.
- Minimal
initial information is collected on each patient (including
age, LMP, exposure, dosage, and timing of exposure).
- At
the time of delivery, the health-care provider is prompted to
provide follow-up data on the pregnancy outcome.
- The Registry strongly encourages prospective enrollment as early in pregnancy as
possible (preferably before any prenatal testing for birth
defects is done) to
maximize the validity of the data.
- "Retrospective"
information that is reported only after the outcome of the
pregnancy is known is accepted.
It should be noted the Registry systematically collects
information on the exposures and information available on major
structural or chromosomal defects reported to the Registry.
Although the Registry does collect information on maternal and
other fetal and perinatal events when provided, the Registry
does not systematically collect these data. These data are sent
to the manufacturers of the products referred to in the report
and reviewed by the Advisory Committee established to oversee
the Registry process and analysis, but are not part of the
Registry analysis. Therefore, reporters are also encouraged to
report any maternal or non-defect fetal and perinatal events to
the manufacturer of the products used and/or the FDA
(Food and Drug Administration).
(Click here for enrollment
procedures.)
back
to the top
|
|
How
are the data collected by the Registry analyzed and reported?
An
important aspect of the Registry is its Advisory Committee. The
scientific conduct and analysis of the Registry are overseen by an
Advisory Committee consisting of members from the Centers for
Disease Control and Prevention (CDC), Food and Drug Administration
(FDA), the National Institutes of Health (NIH), as well as the
private sector. Members include specialists in maternal and fetal
medicine, teratology, infectious disease, epidemiology, and
biostatistics. The Advisory Committee reviews the Registry data,
develops the Advisory Committee Consensus Statement, provides
recommendations on modifications or enhancements to the Registry,
and assists in the dissemination of information and formulation of
strategies to encourage enrollment in the Registry. The Advisory
Committee and the Sponsor Company representatives constitute the
Steering Committee, which jointly manages the general conduct of
the Registry.
The
Advisory Committee meets with representatives of the sponsoring
manufacturers semi-annually with additional interim conference calls, if
needed, to evaluate the Registry data and
assist in disseminating information about the Registry. A Registry
Interim Report is prepared semiannually summarizing the aggregate
data and is available to all interested health-care providers.
(Click
here to request a copy of the current
Interim Report)
back
to the top
|
|
How
does participation benefit me and my patients?
The
Registry is a primary source for evaluating use of antiretroviral
products in pregnancy. Your contribution to this collaborative
monitoring of exposures to antiretrovirals during pregnancy
enables you and your colleagues to obtain information
on available data in the Antiretroviral Pregnancy Registry Interim Report
printed and distributed semi-annually.
back
to the top
|
| The
success of the Registry depends on the continued
participation of health-care providers who register
patients and assist in providing follow-up information
postpartum.
The
support and participation of providers who enroll and
continue to enroll patients are greatly appreciated. |
back
to the top
|
