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Maternal exposure to methotrexate and birth defects: a population-based study.
[congenital diaphragmatic hernia]
Methotrexate
is
an
anti-folate
medication
that
is
associated
with
increased
risk
of
multiple
birth
defects
.
Using
data
from
the
National
Birth
Defects
Prevention
Study
,
a
case-control
study
of
major
birth
defects
in
the
United
States
,
we
examined
mothers
exposed
to
methotrexate
.
The
study
population
included
mothers
of
live-born
infants
without
major
birth
defects
(
controls
)
and
mothers
of
fetuses
or
infants
with
a
major
birth
defect
(
cases
)
,
with
expected
dates
of
delivery
between
October
1997
and
December
2009
.
Mothers
of
cases
and
controls
were
asked
detailed
questions
concerning
pregnancy
history
,
demographic
information
,
and
exposures
in
a
telephone
interview
.
Approximately
0
.
06
%
(
n
=
16
/
27
,
623
)
of
case
and
0
.
04
%
(
n
=
4
/
10
,
113
)
of
control
mothers
reported
exposure
to
methotrexate
between
3
months
prior
to
conception
through
the
end
of
pregnancy
.
Of
the
16
case
infants
,
11
(
68
.
8
%
)
had
a
congenital
heart
defect
(
CHD
)
.
The
observed
CHDs
included
atrial
septal
defects
,
tetralogy
of
Fallot
,
valvar
pulmonary
stenosis
,
ventricular
septal
defects
(
VSDs
)
,
and
total
anomalous
pulmonary
venous
return
.
One
case
infant
had
microtia
in
addition
to
a
VSD
and
another
had
VACTER
association
.
Exposed
cases
without
a
CHD
had
one
of
the
following
birth
defects
:
cleft
palate
,
hypospadias
,
congenital
diaphragmatic
hernia
,
or
craniosynostosis
.
Based
on
a
limited
number
of
methotrexate-exposed
mothers
,
our
findings
support
recent
case
reports
suggesting
an
association
between
early
pregnancy
exposure
to
methotrexate
and
CHDs
.
Because
of
the
rarity
of
maternal
periconceptional
exposure
to
methotrexate
,
long
-term
,
population-based
case-control
studies
are
needed
to
confirm
these
findings
and
better
evaluate
the
association
between
methotrexate
and
birth
defects
.
Diseases
Validation
Diseases presenting
"or craniosynostosis"
symptom
congenital diaphragmatic hernia
dentin dysplasia
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