PLAC1 in Reproduction

Pregnancy Clinical Trial

Official title:

PLAC1 in Reproduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277848
• Other study ID #: IRB#107849
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: October 24, 2017
• Start date: May 2009
• Est. completion date: May 2015

Study information

• Verified date: October 2017
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	USF Health OB/GYN Clinic	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	March of Dimes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-PLAC1 autoantibodies		During pregnancy