Gene Expression In Pregnancies Complicated by Preeclampsia

N/ATerminatedNCT00919360

University of Rochester125 enrolled

Overview

The purpose of this study is to figure out some of the differences in bodily function between women who have preeclampsia and those who do not. * This may eventually lead to an understanding of its cause. At this time, there is no known way to prevent preeclampsia, and the cause is not known. * The only treatment is delivery of the baby, even if it is premature, in order to decrease the risk to the mother.

* Preeclampsia is a pregnancy-related disorder that occurs in about 6% of all pregnancies. * In its mild for, preeclampsia involves high blood pressure. More severe forms of preeclampsia can lead to more serious pregnancy complications. * At this time, there is no known way to prevent preeclampsia, and the cause is not known. The only treatment is delivery of the baby, even if it is premature, in order to decrease the risk to the mother. * The purpose of this study is to figure out some of the differences in bodily function between women who have preeclampsia and those who do not. This may eventually lead to an understanding of its cause.

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Preeclampsia

Interventions

collection of maternal blood specimen prior to deliveryPROCEDURE

approximately 5 cc. of maternal blood will be drawn prior to delivery

collection of placental cord blood after deliveryPROCEDURE

approximately 5 cc. of fetal cord blood from the umbilical cord blood vessel will be collected after cord is clamped

collection of placental tissuePROCEDURE

within 10 minutes of delivery, the placenta will be radially transected, and a full-thickness slice from the central region removed using sterile technique by scalpel.This will be placed into a pre-prepared container of RNA preservation medium.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Gravidas at 32-42 weeks gestation,who have preeclampsia as defined by Sibai et al, 1997. * Control patients: Gravidas without history of hypertension of any kind, and matched to cases for parity, gestational age, labor status, maternal age, and race. Exclusion Criteria: * Prior betamethasone administration, fetal growth restriction (\<3%ile), prior chronic hypertension (nonpregnant or \< 20 weeks gestation any pregnancy), chorioamnionitis, major fetal anomaly or chromosome abnormality, multiple gestation, and maternal diabetes (any class except diet-controlled gestational).

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

Relative pattern of expression in cases and matched controls of a robust set of genes in the VEGF/sFLT mediated model for preeclampsia in the placenta and decidua

Time frame: 1- 2 years

Secondary Outcomes

From this expression pattern,determine the validity of 18s ribosomal subunit as an endogenous control in this tissue.

Time frame: 1- 2 years

Using relative expression analysis in an embedded set of control subjects, determine whether common variables e.g. labor, parity independently influence expression of these genes of interest in the tissues studied

Time frame: 1 - 2 years

Determine the population variance for each gene of interest

Time frame: 1 - 2 years

Data from ClinicalTrials.gov

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