Pregnancy Clinical Trial
Official title:
PLAC1 in Reproduction
The PLAC1 gene is a recently described X-linked gene that maps to a region of the X
chromosome thought to be important for normal fetal and placental development. Elevated
levels of PLAC1 mRNA were detected in preeclampsia and appeared to be directly related to
disease severity. PLAC1 may serve as a useful marker of placental dysfunction or threatened
pregnancy.
The objective of this study is to measure the prevalence of circulating anti-PLAC1 antibodies
in pregnant maternal serum and correlate it with pregnancy outcome. It is likely that women
with these antibodies are at higher risk for adverse pregnancy outcomes. Approximately 5% (50
of 1000) will be expected to have anti-PLAC1 antibodies based on previously reported data.
The prevalence of these antibodies and their clinical impact on pregnancy outcomes will be
determined.
1000 healthy, multiparous and primigravid women will be screened for anti-PLAC1 antibodies at
their routine prenatal clinic visits. Subjects will be enrolled at their first clinic visit
at USF Health, South Tampa Center, Department of Obstetrics. Blood (1.0 ml) will be obtained
as part of the routine blood draw at the time of enrollment. Blood will only be collected
when drawn as part of routine laboratory testing as determined by the primary care provider.
Additional blood samples (1.0 ml) will be collected throughout pregnancy at the same time
blood is obtained for routine or otherwise clinically indicated laboratory testing. A maximum
of 5 samples will be collected through the pregnancy.
Maternal demographic data will be collected and patients will be followed longitudinally to
the completion of pregnancy to ascertain their clinical status during pregnancy, onset of
premature labor, premature rupture of membranes, delivery date, and gestational age at
delivery.
n/a
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