PLAC1 in Reproduction

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT01277848

Collaborator

March of Dimes (Other)

500

Enrollment

Location

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Pregnancy

Study Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

PLAC1 in Reproduction

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Outcome Measures

Primary Outcome Measures

Anti-PLAC1 autoantibodies [During pregnancy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Fant, Principal Investigator, University of South Florida

ClinicalTrials.gov Identifier:

NCT01277848

Other Study ID Numbers:

IRB#107849

First Posted:

Jan 17, 2011

Last Update Posted:

Oct 26, 2017

Last Verified:

Oct 1, 2017

Keywords provided by Michael Fant, Principal Investigator, University of South Florida

Study Results

No Results Posted as of Oct 26, 2017