Gene Expression In Pregnancies Complicated by Preeclampsia
NCT ID: NCT00919360
Last Updated: 2015-10-21
Study Results
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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TERMINATED
125 participants
OBSERVATIONAL
2008-06-30
2015-07-31
Brief Summary
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* 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.
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Detailed Description
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* 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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Study Design
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CASE_CONTROL
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
approximately 5 cc. of maternal blood will be drawn prior to delivery
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
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.
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.
collection of maternal blood specimen prior to delivery
approximately 5 cc. of maternal blood will be drawn prior to delivery
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
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.
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.
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
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
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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University of Rochester
OTHER
Responsible Party
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Monique Ho
Assistant Professor
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
Countries
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Other Identifiers
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RSRB# 22086
Identifier Type: -
Identifier Source: org_study_id
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