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Chronic Hypertension and Pregnancy (CHAP) Project (CHAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02299414
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
Columbia University
Drexel University College of Medicine
Rutgers, The State University of New Jersey
Lehigh Valley Hospital
Saint Peters University Hospital
Christiana Care Health Services
Washington University School of Medicine
Duke University
University of Texas Southwestern Medical Center
The University of Texas Health Science Center, Houston
Stanford University
University of Pennsylvania
The University of Texas Medical Branch, Galveston
University of Utah
Intermountain Health Care, Inc.
University of California, San Francisco
Johns Hopkins University
University of Pittsburgh
Ochsner Health System
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
WakeMed Health and Hospitals
San Francisco General Hospital
McKay-Dee Hospital
Winthrop University Hospital
New York Hospital Queens
Latter Day Saints Hospital
Lyndon B Johnson General Hospital
Virtua Medical Group
Bayview Medical Center
Duke Regional Hospital
Utah Valley Regional Medical Center
Northwestern
Brown (WIHRI)
Baylor College of Medicine
Case Western/Metro Health
Ohio State University
University of Iowa
University of California, San Diego
Indiana University
Unity Point Health-Meriter Hospital WI
Weill Medical College of Cornell University
University of Oklahoma
Medical University of South Carolina
Beaumont Hospital
University of Colorado, Denver
University of Kansas Medical Center
Denver Health and Hospital Authority
Gundersen Health System
Aurora Health Care
Oregon Health and Science University
Medical College of Wisconsin
Temple University
New Jersey Medical School
University of South Alabama
Vanderbilt University
University of Arkansas
Miami Valley Hospital
Emory University
St. Luke's Hospital and Health Network, Pennsylvania
Cleveland Clinic Fairview Hospital
University of Tennessee Health Science Center
TriHealth Inc.
Cleveland Clinic Hillcrest Hospital
Tulane University
Yale University
Arrowhead Regional Medical Center
Geisinger Clinic
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Anti-hypertensive therapy Other: No anti-hypertensive therapy (unless BP is severe) Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pragmatic Multicenter Randomized Clinical Trial (RCT) of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project
Study Start Date : June 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anti-hypertensive therapy to goal <140/90 mmHg
Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used
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 Names:
  • Normodyne
  • Trandate
  • Procardia XL
  • Adalat

Active Comparator: No anti-hypertensive unless BP is severe (≥160/105 mmHg
Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used
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.




Primary Outcome Measures :
  1. Composite adverse perinatal outcome [ Time Frame: Up to 2 weeks after delivery ]
    One of more severe outcomes including fetal or neonatal death up to 2 weeks; preeclampsia with severe features (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).

  2. Small for Gestational Age [ Time Frame: Until delivery ]
    Birth weight less than 10th percentile for gestational age at birth according to accepted national standard


Secondary Outcome Measures :
  1. Composite of maternal death or severe cardiovascular morbidity [ Time Frame: Up to 6 weeks (4-12 weeks) after delivery ]
    One or more of maternal death, heart failure, stroke, encephalopathy, Myocardial infarction or ischemia, pulmonary edema, ICU admission, or renal failure

  2. Composite of severe adverse perinatal outcome [ Time Frame: Up to 6 weeks (4-12 weeks) after delivery ]
    One or more of perinatal death, IVH III or IV, BPD or chronic lung disease, NEC, ROP, Seizures, Proven sepsis

  3. Adherence to treatment after delivery [ Time Frame: Up to 6 weeks (4-12 weeks) after delivery ]
    Adherence to antihypertensive therapy after delivery


Other Outcome Measures:
  1. Preeclampsia [ Time Frame: Up to 2 weeks after delivery ]
    Mild or severe, including eclampsia

  2. Superimposed gestational hypertension [ Time Frame: Enrollment (between 6 and 18 weeks gestation) to delivery ]
    Persistent hypertension above baseline without proteinuria occurring after 20 weeks gestation

  3. Severe hypertension [ Time Frame: Up to 6 weeks (4-12 weeks) after delivery ]
    Blood pressure ≥160/110

  4. Cesarean delivery [ Time Frame: Until delivery ]
    Cesarean delivery

  5. Preterm birth [ Time Frame: At birth ]
    Delivery at <37 weeks

  6. NICU admission [ Time Frame: Up to 6 weeks (4-12 weeks) after delivery ]
    NICU admission and length of NICU stay

  7. Low birth weight [ Time Frame: At birth ]
    Birth weight <2500g

  8. Ponderal index [ Time Frame: At birth ]
    Mean ponderal index

  9. Head circumference [ Time Frame: At birth ]
    Mean head circumference

  10. Placental weight [ Time Frame: At delivery ]
    Mean placental weight

  11. Hypoglycemia [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]
    Prevalence of hypoglycemia

  12. Bradycardia [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]
    Prevalence of bradycardia

  13. Hypotension [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]
    Incidence (%) with hypotension

  14. Respiratory distress syndrome (RDS) [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]
    Incidence (%) with RDS

  15. Bronchopulmonary dysplasia (BPD) [ Time Frame: Up to 3 months after delivery ]
    Incidence (%) with BPD

  16. Intubation/ventilation [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]
    Incidence (%) with intubation for ventilation

  17. Intraventricular hemorrhage (IVH) [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]
    Incidence (%) with any IVH and with IVH Grades III and IV

  18. Necrotizing enterocolitis (NEC) [ Time Frame: Up to 3 months after delivery ]
    Incidence (%) with NEC

  19. Hyperbilirubinemia [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]
    Incidence (%) with hyperbilirubinemia

  20. 5-min Apgar score [ Time Frame: At delivery ]
    Apgar score <7

  21. Sepsis [ Time Frame: From delivery to hospital discharge (2 - 3 days after delivery) ]
    Incidence (%) with sepsis

  22. Unscheduled prenatal clinic or ER visits [ Time Frame: Up to 3 months after delivery ]
    Number of unscheduled clinic or ER visits before and after delivery

  23. Hospitalizations [ Time Frame: Up to 3 months postpartum ]
    Number of hospitalizations before or after delivery

  24. Postpartum unscheduled or ER visits [ Time Frame: Up to 3 months after delivery ]
    Number of postpartum unscheduled or ER visits

  25. Postpartum hospitalizations [ Time Frame: Up to 3 months after delivery ]
    Number of postpartum hospitalizations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299414


Contacts
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Contact: Alan Tita, MD, PhD 205-934-5612 atita@uabmc.edu
Contact: Michelle Feese, MPH 205-975-8633 mfeese@uab.edu

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Locations
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United States, Alabama
University of Alabama at Birmingham, Clinical Coordinating Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Alan T Tita, MD, PhD       atita@uabmc.edu   
Principal Investigator: Alan Tita, MD, PhD         
University of Alabama at Birmingham, Data Coordinating Center Active, not recruiting
Birmingham, Alabama, United States, 35294
University of South Alabama Recruiting
Mobile, Alabama, United States, 36604
Contact: Susan Baker, MD         
Principal Investigator: Susan Baker, MD         
Sub-Investigator: Brian Brocato, MD         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Everett F. Magann, MD       efmagann@uams.edu   
Principal Investigator: Everett F. Magann, MD         
United States, California
Arrowhead Regional Medical Center Recruiting
Colton, California, United States, 92324
Contact: Kristina Roloff, DO, MPH       kristyroloff@gmail.com   
Principal Investigator: Kristina Roloff, DO, MPH         
Sub-Investigator: Suzanne Cao, MD         
University of California, San Diego Completed
San Diego, California, United States, 92110
General Hospital of San Francisco Completed
San Francisco, California, United States, 94110
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Mary Norton, MD    415-353-7865    nortonm@obgyn.ucsf.edu   
Principal Investigator: Mary Norton, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Yasser El-Sayed, MD    650-723-3198    elsayed@stanford.edu   
Principal Investigator: Yasser El-Sayed, MD         
United States, Colorado
University of Colorado Recruiting
Boulder, Colorado, United States, 80204
Contact: Emily Su, MD       emily.su@ucdenver.edu   
Principal Investigator: Emily Su, MD         
Denver Health Recruiting
Denver, Colorado, United States, 80204
Contact: Nikki Nguyen, MD       Nicki.Nguyen@dhha.org   
Principal Investigator: Nikki Nguyen, MD         
Sub-Investigator: Kent Heyborne, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: Uma Reddy, MD       uma.reddy@yale.edu   
Principal Investigator: Uma Reddy, MD         
Sub-Investigator: Heather Lipkind, MD         
United States, Delaware
Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Matthew Hoffman, MD, MPH         
Principal Investigator: Matthew Hoffman, MD, MPH         
Principal Investigator: Richard Derman, MD, MPH         
United States, Florida
University of South Florida Completed
Tampa, Florida, United States, 33606
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Irish Krishna, MD         
Principal Investigator: Irish Krishna, MD         
United States, Illinois
Northwestern Completed
Evanston, Illinois, United States, 60208
United States, Indiana
Indiana University Recruiting
Bloomington, Indiana, United States, 47405
Contact: David M Haas, MD       dahaas@iu.edu   
Principal Investigator: David M Haas, MD         
United States, Iowa
University of Iowa Completed
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center Recruiting
Lawrence, Kansas, United States, 66045
Contact: Marc Parrish, DO       mparrish@kumc.edu   
Principal Investigator: Marc Parrish, DO         
United States, Kentucky
University of Kentucky Completed
Lexington, Kentucky, United States, 40536
United States, Louisiana
Tulane Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Gabriella Pridjian, MD       pridjian@tulane.edu   
Principal Investigator: Gabriella Pridjian, MD         
Sub-Investigator: Cecilia Gambala, MD         
Ochsner Health System/Medical Center Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Sherri Longo, MD    504-842-4151    slongo@ochsner.org   
Principal Investigator: Sherri Longo, MD         
United States, Maryland
Bayview Medical Center Withdrawn
Baltimore, Maryland, United States, 21224
Johns Hopkins University Withdrawn
Baltimore, Maryland, United States, 21287
United States, Michigan
Beaumont Hospital Completed
Royal Oak, Michigan, United States, 48073
United States, Mississippi
University of Mississippi Medical College Recruiting
Jackson, Mississippi, United States, 39216
Contact: Michelle Owens, MD       myowens@umc.edu   
Principal Investigator: Michelle Owens, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: George A Macones, MD, MSCE    314-362-7139    Maconesg@wudosis.wustl.edu   
Principal Investigator: George Macones, MD, MSCE         
Principal Investigator: Methodius Tuuli, MD, MPH         
United States, New Jersey
Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Todd Rosen, MD         
Principal Investigator: Todd Rosen, MD         
St. Peters University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Janelle Faroutan, MD       jforoutan@saintpetersuh.com   
Sub-Investigator: Kristy Palomares, MD         
Principal Investigator: Janelle Faroutan, MD         
New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact: Todd Rosen, MD         
Principal Investigator: Todd Rosen, MD         
Virtua Medical Group Recruiting
Sewell, New Jersey, United States, 08080
Contact: Ronald Librizzi, DO       RLibrizzi@Virtua.ORG   
Principal Investigator: Ronald Librizzi, DO         
United States, New York
New York Presbyterian Queens Recruiting
Flushing, New York, United States, 11355
Contact: Daniel Skupski, MD       dwskupsk@med.cornell.edu   
Principal Investigator: Daniel Skupski, MD         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Wendy Kinzler, MD       wkinzler@winthrop.org   
Principal Investigator: Wendy Kinzler, MD         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Kirsten Cleary, MD    212-305-1527    klc2108@cumc.columbia.edu   
Principal Investigator: Kirsten Cleary, MD         
Principal Investigator: Ron Wapner, MD         
Weill Cornell Recruiting
New York, New York, United States, 10065
Contact: Phyllis August, MD, MPH       paugust@med.cornell.edu   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kim Boggess, MD    919-966-1601    Kim.boggess@med.unc.edu   
Principal Investigator: Kim Boggess, MD         
Duke Regional Medical Center Recruiting
Durham, North Carolina, United States, 27704
Contact: Brenna Hughes, MD       brenna.hughes@duke.edu   
Principal Investigator: Brenna Hughes, MD         
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Brenna Hughes, MD       brenna.hughes@duke.edu   
Principal Investigator: Brenna Hughes, MD         
WakeMed Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Kim Bogess, MD       KBoggess@med.unc.edu   
Principal Investigator: Kim Boggess, MD         
United States, Ohio
TriHealth, Inc Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Mounira Habli, MD         
Principal Investigator: Mounira Habli, MD         
Case Western/Metro Health Recruiting
Cleveland, Ohio, United States, 44109
Contact: Kelly Gibson, MD       kgibson@metrohealth.org   
Sub-Investigator: Edward Chien, MD         
Principal Investigator: Kelly Gibson, MD         
Cleveland Clinic Fairview Completed
Cleveland, Ohio, United States, 44111
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Heather Frey, MD       Heather.Frey@osumc.edu   
Principal Investigator: Heather Frey, MD         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: David S. McKenna, MD         
Principal Investigator: David S. McKenna, MD         
Cleveland Clinic-Hillcrest Hospital Completed
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rodney Edwards, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Leonardo Pereira, MD       pereiral@ohsu.edu   
Principal Investigator: Leonardo Pereira, MD         
United States, Pennsylvania
Lehigh Valley Hospital/Health Network Completed
Allentown, Pennsylvania, United States, 18101
St. Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Joseph Bell, MD       joseph.bell@sluhn.org   
Principal Investigator: Joseph Bell, MD         
Sub-Investigator: Israel Zighelboim, MD         
Geisinger Clinic Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Dhanya Mackeen, MD       admackeen@geisinger.edu   
Principal Investigator: Dhanya Mackeen, MD         
Sub-Investigator: Michael Paglia, MD         
Drexel University College of Medicine Completed
Philadelphia, Pennsylvania, United States, 19019
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lorraine Dugoff, MD       Lorraine.Dugoff@uphs.upenn.edu   
Principal Investigator: Lorraine Dugoff, MD         
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lorraine Dugoff, MD       Lorraine.Dugoff@uphs.upenn.edu   
Principal Investigator: Lorraine Dugoff, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lorraine Dugoff, MD    215-615-3739    Lorraine.Dugoff@uphs.upenn.edu   
Principal Investigator: Lorraine Dugoff, MD         
Temple University Completed
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburg/Magee Women's Center Recruiting
Pittsburgh, Pennsylvania, United States, 15201
Contact: Hyagriv Simhan, MD, MS    412-641-4874    hsimhan@mail.magee.edu   
Principal Investigator: Hyagriv Simhan, MD         
United States, Rhode Island
Brown (WIHRI) Completed
Providence, Rhode Island, United States, 02912
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Eugene Change, MD       changey@musc.edu   
Principal Investigator: Eugene Chang, MD         
United States, Tennessee
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38103
Contact: Giancarlo Mari, MD         
Principal Investigator: Giancarlo Mari, MD         
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sarah Osmundson, MD, MS         
Principal Investigator: Sarah Osmundson, MD, MS         
United States, Texas
UT Southwestern Active, not recruiting
Dallas, Texas, United States, 75390
UT Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: George R Saade, MD    409-747-0482    gsaade@utmb.edu   
Principal Investigator: George Saade, MD         
Lyndon B. Johnson Hospital Withdrawn
Houston, Texas, United States, 77026
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Kjersti Aagard, MD       aagaardt@bcm.edu   
Principal Investigator: Kjersti Aagard, MD         
UT Houston Recruiting
Houston, Texas, United States, 77030
Contact: Baha Sibai, MD       Baha.M.Sibai@uth.tmc.edu   
Sub-Investigator: Sean Blackwell, MD         
Principal Investigator: Baha Sibai, MD         
United States, Utah
McKay Dee Hospital Recruiting
Ogden, Utah, United States, 84403
Contact: Torri Metz, MD       Torri.Metz@hsc.utah.edu   
Principal Investigator: Torri Metz, MD         
Utah Valley Regional Medical Center Completed
Provo, Utah, United States, 84604
Intermountain Healthcare Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Torri Metz, MD       Torri.Metz@hsc.utah.edu   
Principal Investigator: Torri Metz, MD         
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Torri Metz, MD       Torri.Metz@hsc.utah.edu   
Principal Investigator: Torri Metz, MD         
LDS Hospital Completed
Salt Lake City, Utah, United States, 84143
United States, Wisconsin
Gundersen Health System Completed
La Crosse, Wisconsin, United States, 54601
Unity Point Health-Meriter Hospital Recruiting
Madison, Wisconsin, United States, 53715
Contact: Dinesh M Shah, MD       dmshah@wisc.edu   
Principal Investigator: Dinesh M Shah, MD         
Sub-Investigator: Kara Hoppe, MD         
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Kazumasa Hashimoto, MD       'Hashimotokazumasa@marshfieldclinic.org   
Principal Investigator: Kazumasa Hashimoto, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Anna Palatnik, MD         
Principal Investigator: Anna Palatnik, MD         
Aurora Research Institute Completed
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
University of Alabama at Birmingham
Columbia University
Drexel University College of Medicine
Rutgers, The State University of New Jersey
Lehigh Valley Hospital
Saint Peters University Hospital
Christiana Care Health Services
Washington University School of Medicine
Duke University
University of Texas Southwestern Medical Center
The University of Texas Health Science Center, Houston
Stanford University
University of Pennsylvania
The University of Texas Medical Branch, Galveston
University of Utah
Intermountain Health Care, Inc.
University of California, San Francisco
Johns Hopkins University
University of Pittsburgh
Ochsner Health System
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
WakeMed Health and Hospitals
San Francisco General Hospital
McKay-Dee Hospital
Winthrop University Hospital
New York Hospital Queens
Latter Day Saints Hospital
Lyndon B Johnson General Hospital
Virtua Medical Group
Bayview Medical Center
Duke Regional Hospital
Utah Valley Regional Medical Center
Northwestern
Brown (WIHRI)
Baylor College of Medicine
Case Western/Metro Health
Ohio State University
University of Iowa
University of California, San Diego
Indiana University
Unity Point Health-Meriter Hospital WI
Weill Medical College of Cornell University
University of Oklahoma
Medical University of South Carolina
Beaumont Hospital
University of Colorado, Denver
University of Kansas Medical Center
Denver Health and Hospital Authority
Gundersen Health System
Aurora Health Care
Oregon Health and Science University
Medical College of Wisconsin
Temple University
New Jersey Medical School
University of South Alabama
Vanderbilt University
University of Arkansas
Miami Valley Hospital
Emory University
St. Luke's Hospital and Health Network, Pennsylvania
Cleveland Clinic Fairview Hospital
University of Tennessee Health Science Center
TriHealth Inc.
Cleveland Clinic Hillcrest Hospital
Tulane University
Yale University
Arrowhead Regional Medical Center
Geisinger Clinic
Investigators
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Principal Investigator: Alan Tita, MD, PhD University of Alabama at Birmingham - Clinical Coordinating Center
Principal Investigator: Gary Cutter, PhD University of Alabama at Birmingham-Data Coordinating Center

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Responsible Party: Alan Tita, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02299414     History of Changes
Other Study ID Numbers: 1U01HL119242-01 ( U.S. NIH Grant/Contract )
U01HL119242-01 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Keywords provided by Alan Tita, University of Alabama at Birmingham:
Pregnancy
Chronic hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Labetalol
Nifedipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists