Gene Expression In Pregnancies Complicated by Preeclampsia

Terminated

• Conditions: Preeclampsia
• Interventions: 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

• Registration Number: NCT00919360
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-12
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 125

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preeclamptics	collection of placental cord blood after delivery	Gravidas at 32-42 weeks gestation, delivered by Caesarean Section, who have preeclampsia as defined by Sibai et al, 1997.
Preeclamptics	collection of strip of decidua from uterine lining from cesarean section deliveries	Gravidas at 32-42 weeks gestation, delivered by Caesarean Section, who have preeclampsia as defined by Sibai et al, 1997.
Controls	collection of maternal blood specimen prior to delivery	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.
Controls	collection of placental cord blood after delivery	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.
Preeclamptics	collection of maternal blood specimen prior to delivery	Gravidas at 32-42 weeks gestation, delivered by Caesarean Section, who have preeclampsia as defined by Sibai et al, 1997.
Controls	collection of placental tissue	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.
Preeclamptics	collection of placental tissue	Gravidas at 32-42 weeks gestation, delivered by Caesarean Section, who have preeclampsia as defined by Sibai et al, 1997.
Controls	collection of strip of decidua from uterine lining from cesarean section deliveries	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Determine the population variance for each gene of interest	1 - 2 years
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

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States