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PLAC1 in Reproduction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of South Florida.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
March of Dimes
Information provided by (Responsible Party):
Michael Fant, University of South Florida
ClinicalTrials.gov Identifier:
NCT01277848
First received: January 13, 2011
Last updated: December 1, 2014
Last verified: December 2014

January 13, 2011
December 1, 2014
May 2009
May 2015   (final data collection date for primary outcome measure)
Anti-PLAC1 autoantibodies [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01277848 on ClinicalTrials.gov Archive Site
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PLAC1 in Reproduction
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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample
Pregnant women at USF coming in for their first prenatal appointment
Pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1000
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Female
14 Years to 55 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01277848
IRB#107849
Yes
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Michael Fant, University of South Florida
University of South Florida
March of Dimes
Principal Investigator: Michael Fant, MD, PhD University of South Florida
University of South Florida
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP