PreeclampsiaSCOPENCT02357667
The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study
An observational study of Preeclampsia, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will evaluate the differences in cardiovascular parameters between women with severe preterm preeclampsia and those without preeclampsia using echocardiography and maternal blood. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 20 Apr 2017
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will take place on the obstetrical unit at the Hospital of the University of Pennsylvania (HUP) as well as in the outpatient setting. The patient population is primary from the surrounding urban region. The majority receive prenatal care at our institution. Based on fiscal year 2010 at HUP, the mean age was 24 years old and 85% were African American.
Who may be able to join
- African American women who are admitted to the obstetrical unit with a concern for severe preeclampsia. Patients must be preterm (23-36 6/7 weeks) with a live singleton gestation and at least 18 years old. Women will baseline chronic hypertension and women on magnesium will be included.
- African American women obtaining prenatal care in our outpatient setting who meet matching criteria as noted above.
Who cannot join
- Non-African American women, and African women with concern for severe preeclampsia who are admitted 23 weeks or 37 weeks. Women in labor will be excluded. Women with preexisting cardiovascular disease and women who are current smokers will be excluded.
- Unexposed controls:
- Non-African American women and women who are not receiving care at our institution.
- All women who do not speak English and who are unable to be consented will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study will evaluate the differences in cardiovascular parameters between women with severe preterm preeclampsia and those without preeclampsia using echocardiography and maternal blood. The investigators will also look at associations of abnormal cardiovascular findings and immediate complications among a high risk cohort of pregnant African American women.
Read the detailed description
This will be a prospective cohort study. Exposed cases will be admitted to the inpatient obstetrical unit (labor \& delivery or antepartum unit) at the Hospital of the University of Pennsylvania with concern for severe preterm preeclampsia. Unexposed controls will be matched by gestational age and other clinical factors and will be obtained from the outpatient setting (Helen O Dickens clinic or Penn ObGyn Associates at 3701 Market Street). The investigators will compare cardiovascular risk factors between these two groups.
- Conditions
- Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed cases | African American women with concern for severe preterm (37 weeks gestation) preeclampsia who are admitted to the inpatient obstetrical unit at HUP. | |
| Unexposed controls | African American women without preeclampsia or medical comorbidity who are matched by gestational age, maternal age, and BMI in the outpatient setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E)
Measured: 2 years
Angiogenic factors and biomarkers of congestive heart failure (sFlt1)
Measured: 2 years
Secondary outcomes (5)
Other cardiovascular parameters measured on echocardiogram (ventricular arterial coupling, arterial tonometry)
Measured: 2 years
Other angiogenic factors and biomarkers of CHF (VEGF, BNP, troponin, etc)
Measured: 2 years
Postpartum readmission rate
Measured: 2 years
Pulmonary edema during labor and delivery or postpartum
Measured: 2 years
Peripartum cardiomyopathy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2017
- Study completion20 Apr 2017
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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Levine, University of Pennsylvania
- Investigators
- Lisa Levine, MD, Principal investigator, UENN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357667
- Sponsor's protocol ID
- 821592
- Acronym
- SCOPE
- Status last verified
- May 2018
- First submitted
- 28 Jan 2015
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study
- ClinicalTrials.gov ID
- NCT02357667
- Acronym / sponsor ID
- SCOPE / 821592
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 6 Feb 2015 (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.
This study will evaluate the differences in cardiovascular parameters between women with severe preterm preeclampsia and those without preeclampsia using echocardiography and maternal blood. The investigators will also look at associations of abnormal cardiovascular findings and immediate complications among a high risk cohort of pregnant African American women.
Detailed description
This will be a prospective cohort study. Exposed cases will be admitted to the inpatient obstetrical unit (labor \& delivery or antepartum unit) at the Hospital of the University of Pennsylvania with concern for severe preterm preeclampsia. Unexposed controls will be matched by gestational age and other clinical factors and will be obtained from the outpatient setting (Helen O Dickens clinic or Penn ObGyn Associates at 3701 Market Street). The investigators will compare cardiovascular risk factors between these two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed cases | – | –African American women with concern for severe preterm (37 weeks gestation) preeclampsia who are admitted to the inpatient obstetrical unit at HUP. |
| Unexposed controls | – | –African American women without preeclampsia or medical comorbidity who are matched by gestational age, maternal age, and BMI in the outpatient setting. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will take place on the obstetrical unit at the Hospital of the University of Pennsylvania (HUP) as well as in the outpatient setting. The patient population is primary from the surrounding urban region. The majority receive prenatal care at our institution. Based on fiscal year 2010 at HUP, the mean age was 24 years old and 85% were African American.
Key inclusion criteria (2 listed)
- African American women who are admitted to the obstetrical unit with a concern for severe preeclampsia. Patients must be preterm (23-36 6/7 weeks) with a live singleton gestation and at least 18 years old. Women will baseline chronic hypertension and women on magnesium will be included.
- African American women obtaining prenatal care in our outpatient setting who meet matching criteria as noted above.
Key exclusion criteria (4 listed)
- Non-African American women, and African women with concern for severe preeclampsia who are admitted 23 weeks or 37 weeks. Women in labor will be excluded. Women with preexisting cardiovascular disease and women who are current smokers will be excluded.
- Non-African American women and women who are not receiving care at our institution.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E)
Time frame: 2 years
Angiogenic factors and biomarkers of congestive heart failure (sFlt1)
Time frame: 2 years
5 secondary outcomes
Other cardiovascular parameters measured on echocardiogram (ventricular arterial coupling, arterial tonometry)
Time frame: 2 years
Other angiogenic factors and biomarkers of CHF (VEGF, BNP, troponin, etc)
Time frame: 2 years
Postpartum readmission rate
Time frame: 2 years
Pulmonary edema during labor and delivery or postpartum
Time frame: 2 years
Peripartum cardiomyopathy
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
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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.
Lisa Levine, MD principal investigator
UENN
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 Pennsylvania 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 4 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: finished, as of the sponsor's last update on 2 May 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 2 May 2018.