Gene Expression In Pregnancies Complicated by Preeclampsia

This study has suspended participant recruitment.
(PI is no longer at University of Rochester, has moved to University of Florida, Gainesville. PI email now homonq@ufl.edu. Phone is 352-273-7675)
Sponsor:
Collaborator:
Mae Stone Goode Foundation
Information provided by (Responsible Party):
Monique Ho, University of Rochester
ClinicalTrials.gov Identifier:
NCT00919360
First received: June 10, 2009
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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.

Condition Intervention
Preeclampsia
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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Expression of Vascular Endothelial Growth Factor and Its Effectors in Preeclampsia

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • From this expression pattern,determine the validity of 18s ribosomal subunit as an endogenous control in this tissue. [ Time Frame: 1- 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Determine the population variance for each gene of interest [ Time Frame: 1 - 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, placental and decidual tissue


Estimated Enrollment: 125
Study Start Date: June 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919360

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Mae Stone Goode Foundation
Investigators
Principal Investigator: Eva Pressman, MD University of Rochester
  More Information

No publications provided

Responsible Party: Monique Ho, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00919360     History of Changes
Other Study ID Numbers: RSRB# 22086
Study First Received: June 10, 2009
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on September 30, 2014