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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02299414
Other study ID # 1U01HL119242-01
Secondary ID U01HL119242-01
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2015
Est. completion date December 16, 2022

Study information

Verified date May 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

During pregnancy, chronic hypertension (CHTN) is the most common major medical disorder encountered, occurring in 2-6%. The substantial negative effect of CHTN on pregnancy includes a consistent 3- to 5-fold increase in superimposed preeclampsia and adverse perinatal outcomes (fetal or neonatal death, preterm birth -PTB, poor fetal growth and placental abruption) and possibly a 5- to10-fold increase in maternal cardiovascular and other complications (death, cerebrovascular accident, pulmonary edema and acute renal failure). Mild CHTN (BP <160/110) contributes to a large proportion of these adverse outcomes. While antihypertensive treatment of CHTN is standard for the general population, it is uncertain whether treatment during pregnancy reduces maternal or fetal complications, and there are concerns that decreased arterial pressure may reduce fetal blood flow and cause poor fetal growth or small-for-gestational-age (SGA) infants. Some authorities, including the American College of Obstetricians and Gynecologists (ACOG) and American Society of Hypertension (ASH) recommend withholding antihypertensive therapy for mild CHTN, particularly if BP is <160/105-110 mmHg. The recommendation to withhold antihypertensive treatment in pregnancy conflicts with the broader public health goal to reduce BP in those with CHTN and there is no evidence that discontinuing therapy during the brief period of pregnancy affects maternal outcomes (other than reducing the severe hypertension). For over a decade, authorities have consistently called for well-designed and powered trials to delineate the benefits and risks of pharmacologic therapy for CHTN during pregnancy. Therefore, our multicenter consortium proposes the Chronic Hypertension and Pregnancy (CHAP) Project, a large pragmatic randomized trial with a primary aim to evaluate the benefits and harms of pharmacologic treatment of mild CHTN in pregnancy.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Anti-hypertensive therapy
1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
Other:
No anti-hypertensive therapy (unless BP is severe)
Treatment will not be started if blood pressure remains <160/105; for blood pressure =160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Locations

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

Sponsors (69)

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

Country where clinical trial is conducted

United States, 

Outcome

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
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