Gene Expression In Pregnancies Complicated by Preeclampsia

NCT ID: NCT00919360

Last Updated: 2015-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-07-31

Brief Summary

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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

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* 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.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

collection of maternal blood specimen prior to delivery

Intervention Type PROCEDURE

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

collection of placental cord blood after delivery

Intervention Type PROCEDURE

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

collection of placental tissue

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

collection of maternal blood specimen prior to delivery

Intervention Type PROCEDURE

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

collection of placental cord blood after delivery

Intervention Type PROCEDURE

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

collection of placental tissue

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Interventions

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collection of maternal blood specimen prior to delivery

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

Intervention Type 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

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Monique Ho

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Pressman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RSRB# 22086

Identifier Type: -

Identifier Source: org_study_id

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