Status:
SUSPENDED
Preeclampsia: A Marker for Future Cardiovascular Risk in Women
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Preeclampsia
Pregnancy Induced Hypertension
Eligibility:
FEMALE
21-50 years
Phase:
NA
Brief Summary
This study will compare blood vessel and hormone differences between women who have a history of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a history of uncompl...
Eligibility Criteria
Inclusion
- Healthy female premenopausal volunteers, with regular menstrual cycles (at least 8 cycles per year)
- Age 21 to 50 years
- Systolic blood pressure \<140 and \>90 mmHg and diastolic blood pressure \<90 and \>60 mmHg at the screening visit
- Body mass index \< 35 kg/m2
- History of normotensive pregnancy or history of preeclamptic or hypertensive pregnancy within the last 10 years
- No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram)
Exclusion
- Current pregnancy
- Lactation
- Elevated blood pressure (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg)
- Current diagnosis of hypertension
- Current diagnosis of diabetes mellitus
- Personal history of coronary disease, stroke and kidney disease
- Use of prescription medications (with the exception of stable thyroid hormone replacement dose) within 2 weeks of study
- Use of oral contraceptives or other hormone therapy within 3 months of study;
- Renal impairment (estimated GFR\<60)
- Active liver disease (AST, ALT, alkaline phosphatase \> 1.5 times normal);
- Current smoking, defined as smoking within the 6 months before the screening visit
- Current or past recreational drug use
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01519297
Start Date
May 1 2012
End Date
July 1 2019
Last Update
January 17 2019
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115