Gene Expression In Pregnancies Complicated by Preeclampsia

Preeclampsia Clinical Trial

Official title:

Expression of Vascular Endothelial Growth Factor and Its Effectors in Preeclampsia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00919360
• Other study ID #: RSRB# 22086
• Status: Terminated
• Phase: N/A
• First received: June 10, 2009
• Last updated: October 19, 2015
• Start date: June 2008
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Procedure:
• collection of maternal blood specimen prior to delivery
approximately 5 cc. of maternal blood will be drawn prior to delivery
• 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
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	From this expression pattern,determine the validity of 18s ribosomal subunit as an endogenous control in this tissue.		1- 2 years	No
Secondary	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	No
Secondary	Determine the population variance for each gene of interest		1 - 2 years	No