Status:
WITHDRAWN
Treatment Targets for Chronic Hypertension in Pregnancy
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Pregnancy Toxemia
Hypertension
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
This project is a clinical study of women with high blood pressure who become pregnant. Preeclampsia is a syndrome developing at the end of a pregnancy characterized by an abrupt rise in blood pressur...
Detailed Description
Methods: This is a pilot study to examine the feasibility of conducting a larger, multi center randomized control trial. Fifty women with chronic hypertension who are pregnant and are seen in the fir...
Eligibility Criteria
Inclusion
- Pregnant patients will be evaluated for recruitment to 13 6/7 weeks gestation.
- Age 18-50
- Patients will be included for consideration to enter this trial if office blood pressure is \>140/90 mm Hg: systolic \>140 mm Hg, diastolic \>90 mm Hg or both. The average of 3 readings taken a minimum of 5 minutes apart will be recorded as the baseline blood pressure.
- Patients will also be included for consideration to enter this trial if they have known longstanding hypertension DBP \>90 within 2 years of index pregnancy and/or are on antihypertensive medication, regardless of in-office blood pressure if seen in their first trimester.
Exclusion
- Significant target organ damage; at the patient's initial antepartum visit, routine serum creatinine and urine dipstick for protein are performed by the attending obstetrician. If the patient has been hypertensive by history for over 5 years, a screening electrocardiogram will be performed. These will be reviewed for results precluding participation in the trial.
- Known renal disease creatinine \> 1.2 mg/dl
- Proteinuria \>500 mg/day at baseline
- Left ventricular hypertrophy by ECG criteria.
- History of the following: chronic illness requiring immunosuppression, as well as secondary causes of hypertension: pheochromocytoma, hyperaldosteronism, coarctation of aorta, renal artery stenosis not revascularized.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00194974
Start Date
July 1 2004
End Date
March 1 2005
Last Update
January 30 2017
Active Locations (1)
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1
The New York PresbyterianHospital-Weill Medical College of Cornell University
New York, New York, United States, 10021