Hypertension Clinical Trial
— CHAPOfficial title:
A Pragmatic Multicenter Randomized Clinical Trial (RCT) of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project
Verified date | May 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2408 |
Est. completion date | December 16, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 12 Years and older |
Eligibility | 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. Severe hypertension including 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: - Diabetes mellitus diagnosed at age =10 years or duration of diagnosis =20 years - Diabetes mellitus complicated by end organ damage (retinopathy, nephropathy, heart disease, transplant) - Chronic kidney disease - including baseline proteinuria (>300mg/24-hr, protein/creatinine 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. If a p/c ratio is >0.3, the patient may be included if a 24-hour urine is < 300 mg. - 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 and nifedipine (e.g. know hypersensitivity); 12. Current substance abuse or addiction (cocaine, methamphetamine) 13. Participation in another trial without prior approval (CHAP participants will not be enrolled in other trials without prior approval by protocol committee) 14. Physician or provider refusal 15. Patient refusal *The minimum age varies by center |
Country | Name | City | State |
---|---|---|---|
United States | Lehigh Valley Hospital/Health Network | Allentown | Pennsylvania |
United States | Emory University | Atlanta | Georgia |
United States | St. Luke's University Health Network | Bethlehem | Pennsylvania |
United States | University of Alabama at Birmingham, Clinical Coordinating Center | Birmingham | Alabama |
United States | University of Alabama at Birmingham, Data Coordinating Center | Birmingham | Alabama |
United States | Indiana University | Bloomington | Indiana |
United States | University of Colorado | Boulder | Colorado |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | TriHealth, Inc | Cincinnati | Ohio |
United States | Case Western/Metro Health | Cleveland | Ohio |
United States | Cleveland Clinic Fairview | Cleveland | Ohio |
United States | Arrowhead Regional Medical Center | Colton | California |
United States | Ohio State University | Columbus | Ohio |
United States | UT Southwestern | Dallas | Texas |
United States | Geisinger Clinic | Danville | Pennsylvania |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Denver Health | Denver | Colorado |
United States | Duke Regional Medical Center | Durham | North Carolina |
United States | Duke University | Durham | North Carolina |
United States | Northwestern | Evanston | Illinois |
United States | New York Presbyterian Queens | Flushing | New York |
United States | UT Medical Branch | Galveston | Texas |
United States | Baylor College of Medicine | Houston | Texas |
United States | UT Houston | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | University of Mississippi Medical College | Jackson | Mississippi |
United States | Gundersen Health System | La Crosse | Wisconsin |
United States | University of Kansas Medical Center | Lawrence | Kansas |
United States | University of Kentucky | Lexington | Kentucky |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Unity Point Health-Meriter Hospital | Madison | Wisconsin |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Cleveland Clinic-Hillcrest Hospital | Mayfield Heights | Ohio |
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
United States | Aurora Research Institute | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Winthrop University Hospital | Mineola | New York |
United States | University of South Alabama | Mobile | Alabama |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Robert Wood Johnson Medical School | New Brunswick | New Jersey |
United States | St. Peters University Hospital | New Brunswick | New Jersey |
United States | Yale University | New Haven | Connecticut |
United States | Ochsner Health System/Medical Center | New Orleans | Louisiana |
United States | Tulane | New Orleans | Louisiana |
United States | Columbia University | New York | New York |
United States | Weill Cornell | New York | New York |
United States | Christiana Care Health Services | Newark | Delaware |
United States | New Jersey Medical School | Newark | New Jersey |
United States | McKay Dee Hospital | Ogden | Utah |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | Temple University | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburg/Magee Women's Center | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Brown (WIHRI) | Providence | Rhode Island |
United States | Utah Valley Regional Medical Center | Provo | Utah |
United States | WakeMed | Raleigh | North Carolina |
United States | Beaumont Hospital | Royal Oak | Michigan |
United States | Washington University | Saint Louis | Missouri |
United States | Intermountain Healthcare | Salt Lake City | Utah |
United States | LDS Hospital | Salt Lake City | Utah |
United States | University of Utah | Salt Lake City | Utah |
United States | University of California, San Diego | San Diego | California |
United States | General Hospital of San Francisco | San Francisco | California |
United States | University of California San Francisco | San Francisco | California |
United States | Virtua Medical Group | Sewell | New Jersey |
United States | Stanford University | Stanford | California |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | 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, 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, Premier Health Miami Valley Hospital, 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, 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 |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Superimposed Preeclampsia | Mild or severe, including eclampsia | Up to 2 weeks after delivery | |
Other | Superimposed Gestational Hypertension | Persistent worsening hypertension above baseline without pree or proteinuria occurring after 20 weeks gestation | Enrollment (between 6 and 18 weeks gestation) to delivery | |
Other | Severe Hypertension | Blood pressure =160/110 | Up to 6 weeks (4-12 weeks) after delivery | |
Other | Cesarean Delivery | Cesarean delivery | Until delivery | |
Other | Blood Transfusion | During pregnancy or postpartum | Up to 6 weeks | |
Other | NICU Admission | Any NICU admission | Up to 6 weeks (4-12 weeks) after delivery | |
Other | Low Birth Weight | Birth weight <2500g | At birth | |
Other | Ponderal Index | Mean ponderal index, mass/height^3 at birth | At birth | |
Other | Head Circumference | Mean head circumference | At birth | |
Other | Placental Weight | Mean placental weight | At delivery | |
Other | Hypoglycemia | Prevalence of hypoglycemia | From delivery to hospital discharge (2 - 3 days after delivery) | |
Other | Bradycardia | Prevalence of bradycardia | From delivery to hospital discharge (2 - 3 days after delivery) | |
Other | Hypotension | Incidence (%) with hypotension | From delivery to hospital discharge (2 - 3 days after delivery) | |
Other | Respiratory Distress Syndrome (RDS) | Incidence (%) with respiratory distress syndrome (RDS) | From delivery to hospital discharge (2 - 3 days after delivery) | |
Other | Bronchopulmonary Dysplasia (BPD) | Incidence (%) with bronchopulmonary dysplasia (BPD) | Up to 3 months after delivery | |
Other | Intubation/Ventilation | Incidence (%) with resuscitation including oxygen, intubation, chest compression/CPR, or CPAP | From delivery to hospital discharge (2 - 3 days after delivery) | |
Other | Intraventricular Hemorrhage (IVH) | Incidence (%) with any IVH and with IVH Grades III and IV | From delivery to hospital discharge (2 - 3 days after delivery) | |
Other | Necrotizing Enterocolitis (NEC) | Incidence (%) with necrotizing enterocolitis (NEC) | Up to 3 months after delivery | |
Other | Hyperbilirubinemia | Incidence (%) with hyperbilirubinemia | From delivery to hospital discharge (2 - 3 days after delivery) | |
Other | 5-min Apgar Score | Incidence (%) with Apgar score <7 (range 0-10 with lower scores indicating worse outcome) | At delivery | |
Other | Sepsis | Incidence (%) with proven sepsis | From delivery to hospital discharge (2 - 3 days after delivery) | |
Other | Unscheduled Prenatal Clinic or ER Visits | Number of unscheduled clinic or ER visits before and after delivery | Up to 3 months after delivery | |
Other | Hospitalizations | Number of hospitalizations before or after delivery | Up to 3 months postpartum | |
Other | Postpartum Unscheduled or ER Visits | Number of postpartum unscheduled or ER visits | Up to 3 months after delivery | |
Other | Postpartum Hospitalizations | Number of postpartum hospitalizations | Up to 3 months after delivery | |
Other | Neonatal Hospital Stay of 3 or More Days | Frequency of neonatal hospital stays lasting at least 3 days | after delivery | |
Primary | Composite Adverse Perinatal Outcome | One or more severe outcomes including fetal death or neonatal death up to discharge or 90 days if prior; preeclampsia with severe features up to 2 weeks postpartum (Severe hypertension and proteinuria or hypertension and severe features per ACOG); placental abruption; or indicated PTB <35 weeks (not due to spontaneous preterm labor or membrane rupture). | Up to 2 weeks postpartum for preeclampsia or 90 days for neonatal death | |
Primary | Small for Gestational Age (Safety) | Birth weight less than 10th percentile for gestational age at birth according to accepted national standard | Until delivery | |
Secondary | Composite of Maternal Death or Severe Cardiovascular Morbidity | One or more of maternal death, new heart failure, stroke, encephalopathy, angina, myocardial infarction or ischemia, pulmonary edema, ICU admission/intubation, or renal failure | Up to 6 weeks (4-12 weeks) after delivery | |
Secondary | Severe Maternal Hypertension + Components of the Primary Composite Endpoint | Persistent severe hypertension with or without proteinuria + the primary composite | Up to 2 weeks postpartum or 90 days for neonatal death | |
Secondary | Preterm Birth and Indicated Preterm Birth (<37 Weeks) | Preterm birth and Indicated preterm birth (<37 weeks) includes any preterm birth less than 37 weeks | Until delivery | |
Secondary | Composite of Severe Neonatal Morbidities | One or more of Bronchopulmonary dysplasia (BPD), Retinopathy of prematurity (ROP), Necrotizing enterocolitis (NEC), Intraventricular hemorrhage (VH) grade III/IV | Up to 90 days post delivery | |
Secondary | Adherence to Treatment After Delivery | Counts with high adherence to antihypertensive therapy after delivery for those prescribed medications. | 6 weeks (4-12 weeks) after delivery |
Status | Clinical Trial | Phase | |
---|---|---|---|
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