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Sponsored by: |
Weill Medical College of Cornell University |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00194974 |
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 | Intervention | Phase |
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Pregnancy Toxemia Hypertension Proteinuria |
Drug: methyldopa Drug: labetalol Drug: nifedipine Drug: clonidine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment Targets for Chronic Hypertension in Pregnancy |
Estimated Enrollment: | 50 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | June 2007 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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.
Contact: Phyllis August, MD MPH | 212-746-2210 | paugust@med.cornell.edu |
Contact: Tiina Podymow, MD | 212-746-2210 | tip2002@med.cornell.edu |
United States, New York | |
The New York PresbyterianHospital-Weill Medical College of Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Phyllis August, MD MPH 212-746-2210 paugust@med.cornell.edu | |
Principal Investigator: Phyllis August, MD MPH | |
Sub-Investigator: Daniel Skupski, MD | |
Sub-Investigator: Tiina Podymow, MD |
Principal Investigator: | Phyllis August, MD MPH | The New York PresbyterianHospital-Weill Medical College of Cornell University |
Study ID Numbers: | 0304-191 |
Study First Received: | September 13, 2005 |
Last Updated: | April 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00194974 |
Health Authority: | United States: Institutional Review Board |
pregnancy chronic hypertension Toxemia Blood Pressure |
Pregnancy Complications Eclampsia Urination Disorders Clonidine Vascular Diseases Pre-Eclampsia Methyldopa Preeclampsia Nifedipine |
Toxemia Labetalol Calcium, Dietary Signs and Symptoms Proteinuria Hypertension, Pregnancy-Induced Urologic Diseases Pregnancy toxemia /hypertension Hypertension |
Vasodilator Agents Sympatholytics Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Blockers Reproductive Control Agents Adrenergic alpha-Antagonists Cardiovascular Agents Infection |
Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions Membrane Transport Modulators Urological Manifestations Tocolytic Agents Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Peripheral Nervous System Agents |