Treatment Targets for Chronic Hypertension in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00194974
First received: September 13, 2005
Last updated: April 26, 2006
Last verified: September 2005
  Purpose

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
Pregnancy Toxemia
Hypertension
Proteinuria
Drug: methyldopa
Drug: labetalol
Drug: nifedipine
Drug: clonidine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Targets for Chronic Hypertension in Pregnancy

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

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

Secondary Outcome Measures:
  • The incidence of superimposed preeclampsia
  • Gestational age
  • Birth weight < 10th centile for gestational age
  • Serious perinatal complications

Estimated Enrollment: 50
Study Start Date: July 2004
Estimated Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194974

Contacts
Contact: Phyllis August, MD MPH 212-746-2210 paugust@med.cornell.edu
Contact: Tiina Podymow, MD 212-746-2210 tip2002@med.cornell.edu

Locations
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         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Phyllis August, MD MPH The New York PresbyterianHospital-Weill Medical College of Cornell University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00194974     History of Changes
Other Study ID Numbers: 0304-191
Study First Received: September 13, 2005
Last Updated: April 26, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
pregnancy
chronic hypertension
Toxemia
Blood Pressure

Additional relevant MeSH terms:
Hypertension
Proteinuria
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Toxemia
Vascular Diseases
Cardiovascular Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Pregnancy Complications
Infection

ClinicalTrials.gov processed this record on October 16, 2014