View Clinical Trial (Medical Research Study)
PLAC1 in Reproduction
| City: |
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Tampa |
| State: |
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Florida |
| Zip Code: |
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33606 |
| Conditions: |
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Pregnant Women |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Pregnant, primigravid and multigravid women between the ages of 14 and 55, receiving
prenatal care at USF Health, STC, Dept. of Obstetrics.
Exclusion Criteria:
- presence of significant cardiac disease
- renal disease
- chronic hypertension
- chromosomal abnormalities
- cancer
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| NCT ID: |
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NCT01277848 |
| Primary Contact: |
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Principal Investigator
Michael Fant, MD, PhD
USF
Nicole Nations, RN, BSN
Phone: (813) 259-8848
Email: nnation1@health.usf.edu
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| Backup Contact: |
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Email: jzaritt@health.usf.edu
Judy Zaritt, RN, BS
Phone: (813) 259-8746
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| Location Contact: |
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Tampa, Florida 33606
United States
Nicole Nations, RN, BSN
Phone: 813-259-8848
Email: nnation1@health.usf.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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