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NCT01277848 · ClinicalTrials.gov registry record

PLAC1 in Reproduction

A clinical trial of Pregnancy, sponsored by University of South Florida.

Completed
Registry status
500
Enrollment target
1
Study location

NCT01277848 is a study of Pregnancy that has completed, run by University of South Florida. The registered enrollment target is 500 participants, below the 870-participant average among 191 other Pregnancy trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01277848, a study of Pregnancy, has completed, sponsored by University of South Florida.

COMPLETED
Registry status
500 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Study Locations (1)

Florida

  • USF Health OB/GYN Clinic - Tampa

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2009-05
Est. Completion 2015-05

Sponsor

University of South Florida

252 total trials

What the Registry Record Tells You About NCT01277848

The ClinicalTrials.gov registry entry for NCT01277848 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 870-participant average among 191 other Pregnancy trials with a reported enrollment target (43% lower). The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 0 interventions.

NCT01277848 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT01277848 about?

NCT01277848 is a clinical study titled "PLAC1 in Reproduction". 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...

What is the current status of trial NCT01277848?

This trial is currently completed. The enrollment target is 500 participants. The study started on 2009-05. Estimated completion is 2015-05.

What conditions does trial NCT01277848 study?

This clinical trial studies the following conditions: Pregnancy.

Who is sponsoring clinical trial NCT01277848?

This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01277848 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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