Gene Expression In Pregnancies Complicated by Preeclampsia

October 19, 2015 updated by: Monique Ho, University of Rochester

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 1- 2 years
1- 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
From this expression pattern,determine the validity of 18s ribosomal subunit as an endogenous control in this tissue.
Time Frame: 1- 2 years
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
Time Frame: 1 - 2 years
1 - 2 years
Determine the population variance for each gene of interest
Time Frame: 1 - 2 years
1 - 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RSRB# 22086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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