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PLAC1 in Reproduction

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ClinicalTrials.gov Identifier: NCT01277848
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
March of Dimes
Information provided by (Responsible Party):
Michael Fant, University of South Florida

Brief Summary:

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.


Condition or disease
Pregnancy

Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PLAC1 in Reproduction
Study Start Date : May 2009
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Anti-PLAC1 autoantibodies [ Time Frame: During pregnancy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women at USF coming in for their first prenatal appointment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277848


Locations
United States, Florida
USF Health OB/GYN Clinic
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
March of Dimes
Investigators
Principal Investigator: Michael Fant, MD, PhD University of South Florida

Responsible Party: Michael Fant, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT01277848     History of Changes
Other Study ID Numbers: IRB#107849
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Michael Fant, University of South Florida:
PLAC1
pregnant
first prenatal visit
pre-eclampsia