PLAC1 in Reproduction
|ClinicalTrials.gov Identifier: NCT01277848|
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : October 26, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||PLAC1 in Reproduction|
|Study Start Date :||May 2009|
|Primary Completion Date :||May 2015|
|Study Completion Date :||May 2015|
- Anti-PLAC1 autoantibodies [ Time Frame: During pregnancy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277848
|United States, Florida|
|USF Health OB/GYN Clinic|
|Tampa, Florida, United States, 33606|
|Principal Investigator:||Michael Fant, MD, PhD||University of South Florida|