Treatment Targets for Chronic Hypertension in Pregnancy
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- The achievement of target blood pressure obtained at every six weeks visits: weeks 20, 26, 32 and 38
- 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 |
Inclusion Criteria:
- 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 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.
- 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.
Contacts and Locations| 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 |
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, Pregnancy-Induced Pregnancy Complications Hypertension Pre-Eclampsia Toxemia Sepsis Proteinuria Vascular Diseases Cardiovascular Diseases Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Urination Disorders Urologic Diseases |
Urological Manifestations Signs and Symptoms Clonidine Labetalol Methyldopa Nifedipine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists |
ClinicalTrials.gov processed this record on June 17, 2013