NCT00919360

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

7.1 years

First QC Date

June 10, 2009

Last Update Submit

October 19, 2015

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

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 deliveryProcedure: collection of placental cord blood after deliveryProcedure: collection of placental tissueProcedure: collection of strip of decidua from uterine lining from cesarean section deliveries

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 deliveryProcedure: collection of placental cord blood after deliveryProcedure: collection of placental tissueProcedure: collection of strip of decidua from uterine lining from cesarean section deliveries

Interventions

collection of maternal blood specimen prior to deliveryPROCEDURE

approximately 5 cc. of maternal blood will be drawn prior to delivery

ControlsPreeclamptics
collection of placental cord blood after deliveryPROCEDURE

approximately 5 cc. of fetal cord blood from the umbilical cord blood vessel will be collected after cord is clamped

ControlsPreeclamptics
collection of placental tissuePROCEDURE

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.

ControlsPreeclamptics
collection of strip of decidua from uterine lining from cesarean section deliveriesPROCEDURE

A strip of decidua will be removed from the upper lip of uterine incision by the surgeon and placed in RNA preservation medium.

ControlsPreeclamptics

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gravidas at 32-42 weeks gestation who present to Labor and Delivery units at University of Rochester, Strong Memorial Hospital

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, placental and decidual tissue

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Eva Pressman, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 12, 2009

Study Start

June 1, 2008

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

US(1)