Treatment Targets for Chronic Hypertension in Pregnancy

NCT00194974 | Withdrawn Phase 1

• 1 other identifier: 0304-191
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Toxemia; Hypertension; Proteinuria

Keywords

pregnancy; chronic hypertension; Toxemia; Blood Pressure

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• The incidence of superimposed preeclampsia

• Gestational age

• Birth weight < 10th centile for gestational age

• Serious perinatal complications

Interventions

methyldopa DRUG

labetalol DRUG

nifedipine DRUG

clonidine DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

The New York PresbyterianHospital-Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension; Proteinuria; Toxemia

Interventions

Methyldopa; Labetalol; Nifedipine; Clonidine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Ethanolamines; Amino Alcohols; Alcohols; Salicylamides; Amides; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles

Study Officials

• Phyllis August, MD MPH

  The New York PresbyterianHospital-Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: July 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: January 30, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)