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