Gene Expression In Pregnancies Complicated by Preeclampsia

Expression of Vascular Endothelial Growth Factor and Its Effectors in Preeclampsia

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.

Study Overview

• Status: Terminated
• Conditions: Preeclampsia
• Intervention / Treatment: Procedure: collection of maternal blood specimen prior to delivery; Procedure: collection of placental cord blood after delivery; Procedure: collection of placental tissue; Procedure: collection of strip of decidua from uterine lining from cesarean section deliveries

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.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls; Gravidas without history of hypertension of any kind, and matched to cases for parity, gestational age, labor status, mode of delivery, maternal age, and race.	Procedure: collection of maternal blood specimen prior to delivery; approximately 5 cc. of maternal blood will be drawn prior to delivery; Procedure: collection of placental cord blood after delivery; approximately 5 cc. of fetal cord blood from the umbilical cord blood vessel will be collected after cord is clamped; Procedure: collection of placental tissue; 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.; Procedure: collection of strip of decidua from uterine lining from cesarean section deliveries; A strip of decidua will be removed from the upper lip of uterine incision by the surgeon and placed in RNA preservation medium.
Preeclamptics; Gravidas at 32-42 weeks gestation, delivered by Caesarean Section, who have preeclampsia as defined by Sibai et al, 1997.	Procedure: collection of maternal blood specimen prior to delivery; approximately 5 cc. of maternal blood will be drawn prior to delivery; Procedure: collection of placental cord blood after delivery; approximately 5 cc. of fetal cord blood from the umbilical cord blood vessel will be collected after cord is clamped; Procedure: collection of placental tissue; 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.; Procedure: collection of strip of decidua from uterine lining from cesarean section deliveries; A strip of decidua will be removed from the upper lip of uterine incision by the surgeon and placed in RNA preservation medium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1- 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
From this expression pattern,determine the validity of 18s ribosomal subunit as an endogenous control in this tissue.	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	1 - 2 years
Determine the population variance for each gene of interest	1 - 2 years

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 12, 2009

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: RSRB# 22086