Clinical trial NCT00919360: Gene Expression In Pregnancies Complicated by Preeclampsia
Official title: Expression of Vascular Endothelial Growth Factor and Its Effectors in Preeclampsia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Preeclampsia
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gravidas at 32-42 weeks gestation who present to Labor and Delivery units at University of Rochester, Strong Memorial Hospital

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: 1- 2 years
Secondary outcomes:
measure: From this expression pattern,determine the validity of 18s ribosomal subunit as an endogenous control in this tissue.
timeFrame: 1- 2 years
measure: 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
timeFrame: 1 - 2 years
measure: Determine the population variance for each gene of interest
timeFrame: 1 - 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Eva Pressman, MD
role: PRINCIPAL_INVESTIGATOR
References: