PLAC1 in Reproduction

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of South Florida
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: June 14, 2012
Last verified: June 2012
  Purpose

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
Pregnant Women

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: PLAC1 in Reproduction

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Estimated Enrollment: 1000
Study Start Date: May 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   14 Years to 55 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277848

Contacts
Contact: Nicole Nations, RN, BSN (813) 259-8848 nnation1@health.usf.edu
Contact: Judy Zaritt, RN, BS (813) 259-8746 jzaritt@health.usf.edu

Locations
United States, Florida
USF Health OB/GYN Clinic Recruiting
Tampa, Florida, United States, 33606
Contact: Nicole Nations, RN, BSN    813-259-8848    nnation1@health.usf.edu   
Contact: Judy Zaritt, RN, BS    (813) 259-8746    jzaritt@health.usf.edu   
Principal Investigator: Michael Fant, MD, PhD         
Sub-Investigator: Valerie Whiteman, MD         
Sponsors and Collaborators
University of South Florida
March of Dimes
Investigators
Principal Investigator: Michael Fant, MD, PhD USF
  More Information

No publications provided

Responsible Party: Michael Fant, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT01277848     History of Changes
Other Study ID Numbers: IRB#107849
Study First Received: January 13, 2011
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014