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Treatment Targets for Chronic Hypertension in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00194974
Recruitment Status : Withdrawn (Lack of funding)
First Posted : September 19, 2005
Last Update Posted : January 30, 2017
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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 pressure (BP), blood clotting and kidney dysfunction, and may result in premature delivery, infant death, and maternal bleeding, kidney failure and stroke. The goal is to determine whether lowering blood pressure to a normal pressure of 120/80 is associated with a lower incidence of preeclampsia. Women who are completely healthy have a 5% chance of developing preeclampsia, however women with preexisting high blood pressure have a 25% chance of this complication. Several studies, including our own suggest that higher blood pressure early in pregnancy (<20 weeks) is associated with an even higher risk of preeclampsia. Currently we, the researchers at Weill Medical College of Cornell University, do not know how to treat women with high blood pressure and/or kidney disease during pregnancy. Keeping the BP in the normal range may be beneficial to the mother. On the other hand, we are not sure if the blood pressure lowering or the medications may or may not have adverse effects for the baby. Different trials to answer this question have been performed with no clear conclusions. Because of these uncertainties, we propose to compare two different strategies for treating women with high BP who become pregnant. We will treat half the women with BP medications to normalize BP (120-130/80 mm Hg) (experimental group) and the other half with the goal of keeping the BP slightly higher (140-150/90-100 mm Hg)(standard therapy group). We will determine which approach results in healthier pregnancies, and lower incidence of preeclampsia. Reducing the incidence of preeclampsia would be of significant benefit to both mothers and babies.

Condition or disease Intervention/treatment Phase
Pregnancy Toxemia Hypertension Proteinuria Drug: methyldopa Drug: labetalol Drug: nifedipine Drug: clonidine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Targets for Chronic Hypertension in Pregnancy
Study Start Date : July 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The achievement of target blood pressure obtained at every six weeks visits: weeks 20, 26, 32 and 38

Secondary Outcome Measures :
  1. The incidence of superimposed preeclampsia
  2. Gestational age
  3. Birth weight < 10th centile for gestational age
  4. Serious perinatal complications

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Pregnant patients will be evaluated for recruitment to 13 6/7 weeks gestation.
  2. Age 18-50
  3. 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.
  4. 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 Criteria:

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.

  1. Known renal disease creatinine > 1.2 mg/dl
  2. Proteinuria >500 mg/day at baseline
  3. Left ventricular hypertrophy by ECG criteria.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00194974

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United States, New York
The New York PresbyterianHospital-Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
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Principal Investigator: Phyllis August, MD MPH The New York PresbyterianHospital-Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University Identifier: NCT00194974    
Other Study ID Numbers: 0304-191
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study terminated
Keywords provided by Weill Medical College of Cornell University:
chronic hypertension
Blood Pressure
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Pregnancy Complications
Systemic Inflammatory Response Syndrome
Pathologic Processes
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists