Overview

Chronic Hypertension and Pregnancy (CHAP) Project

Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborators:
Arrowhead Regional Medical Center
Aurora Health Care
Baylor College of Medicine
Bayview Medical Center
Beaumont Hospital
Brown (WIHRI)
Case Western/Metro Health
Christiana Care Health Services
Cleveland Clinic Fairview Hospital
Cleveland Clinic Hillcrest Hospital
Columbia University
Denver Health and Hospital Authority
Drexel University College of Medicine
Duke Regional Hospital
Duke University
Emory University
Geisinger Clinic
Gundersen Health System
Indiana University
Intermountain Health Care, Inc.
Johns Hopkins University
Latter Day Saints Hospital
Lehigh Valley Hospital
Lyndon B Johnson General Hospital
McKay-Dee Hospital
Medical College of Wisconsin
Medical University of South Carolina
Miami Valley Hospital
National Heart, Lung, and Blood Institute (NHLBI)
New Jersey Medical School
New York Hospital Queens
Northwestern
Ochsner Health System
Ohio State University
Oregon Health and Science University
Rutgers, The State University of New Jersey
Saint Peters University Hospital
San Francisco General Hospital
St. Luke's Hospital and Health Network, Pennsylvania
Stanford University
Temple University
The University of Texas Health Science Center, Houston
The University of Texas Medical Branch, Galveston
TriHealth Inc.
Tulane University
Unity Point Health-Meriter Hospital WI
University of Arkansas
University of California, San Diego
University of California, San Francisco
University of Colorado, Denver
University of Iowa
University of Kansas Medical Center
University of North Carolina, Chapel Hill
University of Oklahoma
University of Pennsylvania
University of Pittsburgh
University of South Alabama
University of Tennessee Health Science Center
University of Texas Southwestern Medical Center
University of Utah
Utah Valley Regional Medical Center
Vanderbilt University
Virtua Medical Group
WakeMed Health and Hospitals
Washington University School of Medicine
Weill Medical College of Cornell University
Winthrop University Hospital
Yale University
Treatments:
Antihypertensive Agents
Nifedipine
Criteria
Inclusion Criteria:

1. Women with chronic hypertension in pregnancy with new or untreated chronic
hypertension, blood pressure 140-159 systolic or 90-104 diastolic OR known chronic
hypertension on monotherapy and taking any antihypertensive and blood pressure
≤159/104 (including those with blood pressure <140/90);

2. Singleton; and

3. viable pregnancy <23 weeks of gestation.

Exclusion Criteria:

1. Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or
without treatment);

2. Patients currently treated with >1 antihypertensive medication (more likely to have
severe chronic hypertension);

3. Multi-fetal pregnancy;

4. Known secondary cause of chronic hypertension;

5. High-risk co-morbidities for which treatment may be indicated:

- Class C or higher diabetes mellitus

- Chronic kidney disease - including baseline proteinuria (>300mg/24-hr, p/c ratio
>0.3, or persistent 1+ proteinuria*) or creatinine >1.2.

*If a dipstick value at screening is more than trace, a clean catch or catheter
urine should be obtained and re-tested by dipstick. If this shows trace or
absence of protein, the patient is included. If it again shows 1+ protein, the
patient is excluded until a 24-hr urine <300mg/24hr or p/c ratio is <0.3.

- Cardiac disorders: cardiomyopathy, angina, CAD

- Prior stroke

- Retinopathy

- Sickle cell disease;

6. Known major fetal anomaly;

7. Known fetal demise;

8. Suspected IUGR;

9. Membrane rupture or planned termination prior to randomization;

10. Plan to deliver outside the consortium centers (unless approved by the Clinical
Coordinating Center) or unlikely to follow-up in the opinion of study staff or
previous participation in this trial;

11. Contraindication to labetalol or nifedipine (e.g. know hypersensitivity); and (12)
Current substance abuse or addiction (cocaine, methamphetamine) *The minimum age
varies by center