PreeclampsiaNCT00919360
Gene Expression In Pregnancies Complicated by Preeclampsia
An observational study of Preeclampsia, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- collection of maternal blood specimen prior to delivery, collection of placental cord blood after delivery and collection of placental tissue
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Gravidas at 32-42 weeks gestation who present to Labor and Delivery units at University of Rochester, Strong Memorial Hospital
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: 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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- collection of maternal blood specimen prior to delivery, collection of placental cord blood after delivery, collection of placental tissue, collection of strip of decidua from uterine lining from cesarean section deliveries
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of maternal blood specimen prior to deliveryProcedure or surgery
approximately 5 cc. of maternal blood will be drawn prior to delivery
collection of placental cord blood after deliveryProcedure or surgery
approximately 5 cc. of fetal cord blood from the umbilical cord blood vessel will be collected after cord is clamped
collection of placental tissueProcedure or surgery
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 deliveriesProcedure or surgery
A strip of decidua will be removed from the upper lip of uterine incision by the surgeon and placed in RNA preservation medium.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 | |
| Preeclamptics | Gravidas at 32-42 weeks gestation, delivered by Caesarean Section, who have preeclampsia as defined by Sibai et al, 1997. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1- 2 years
Secondary outcomes (3)
From this expression pattern,determine the validity of 18s ribosomal subunit as an endogenous control in this tissue.
Measured: 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
Measured: 1 - 2 years
Determine the population variance for each gene of interest
Measured: 1 - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJun 2008
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique Ho, University of Florida
- Investigators
- Eva Pressman, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919360
- Sponsor's protocol ID
- RSRB# 22086
- Status last verified
- Oct 2015
- First submitted
- 10 Jun 2009
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Vascular Endothelial Growth Factor and Its Effectors in Preeclampsia
- ClinicalTrials.gov ID
- NCT00919360
- Acronym / sponsor ID
- RSRB# 22086
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | 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 deliveriesGravidas without history of hypertension of any kind, and matched to cases for parity, gestational age, labor status, mode of delivery, maternal age, and race. |
| Preeclamptics | – | 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 deliveriesGravidas at 32-42 weeks gestation, delivered by Caesarean Section, who have preeclampsia as defined by Sibai et al, 1997. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Gravidas at 32-42 weeks gestation who present to Labor and Delivery units at University of Rochester, Strong Memorial Hospital
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of maternal blood specimen prior to deliveryapproximately 5 cc. of maternal blood will be drawn prior to delivery | Procedure or surgery | Controls, Preeclamptics |
| collection of placental cord blood after deliveryapproximately 5 cc. of fetal cord blood from the umbilical cord blood vessel will be collected after cord is clamped | Procedure or surgery | Controls, Preeclamptics |
| collection of placental tissuewithin 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 or surgery | Controls, Preeclamptics |
| collection of strip of decidua from uterine lining from cesarean section deliveriesA strip of decidua will be removed from the upper lip of uterine incision by the surgeon and placed in RNA preservation medium. | Procedure or surgery | Controls, Preeclamptics |
Primary outcome
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
3 secondary outcomes
From this expression pattern,determine the validity of 18s ribosomal subunit as an endogenous control in this tissue.
Time frame: 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
Determine the population variance for each gene of interest
Time frame: 1 - 2 years
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Pressman, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.