Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
2408 participants
INTERVENTIONAL
2015-06-30
2022-12-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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)
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
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.
Interventions
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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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Singleton; and
3. viable pregnancy \<23 weeks of gestation.
Exclusion Criteria
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
12 Years
FEMALE
No
Sponsors
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Columbia University
OTHER
Drexel University College of Medicine
OTHER
Rutgers, The State University of New Jersey
OTHER
Lehigh Valley Hospital
OTHER
Saint Peters University Hospital
OTHER
Christiana Care Health Services
OTHER
Washington University School of Medicine
OTHER
Duke University
OTHER
University of Texas Southwestern Medical Center
OTHER
The University of Texas Health Science Center, Houston
OTHER
Stanford University
OTHER
University of Pennsylvania
OTHER
The University of Texas Medical Branch, Galveston
OTHER
University of Utah
OTHER
Intermountain Health Care, Inc.
OTHER
University of California, San Francisco
OTHER
Johns Hopkins University
OTHER
University of Pittsburgh
OTHER
Ochsner Health System
OTHER
University of North Carolina, Chapel Hill
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
WakeMed Health and Hospitals
OTHER
San Francisco General Hospital
OTHER
McKay-Dee Hospital
OTHER
Winthrop University Hospital
OTHER
New York Hospital Queens
OTHER
Latter Day Saints Hospital
OTHER
Lyndon B Johnson General Hospital
OTHER
Virtua Medical Group
OTHER
Duke Regional Hospital
OTHER
Utah Valley Regional Medical Center
OTHER
Northwestern University
OTHER
Women and Infants Hospital of Rhode Island
OTHER
Baylor College of Medicine
OTHER
Case Western/Metro Health
UNKNOWN
Ohio State University
OTHER
University of Iowa
OTHER
University of California, San Diego
OTHER
Indiana University
OTHER
Meriter Foundation
OTHER
Weill Medical College of Cornell University
OTHER
University of Oklahoma
OTHER
Medical University of South Carolina
OTHER
Beaumont Hospital
OTHER
University of Colorado, Denver
OTHER
University of Kansas Medical Center
OTHER
Denver Health and Hospital Authority
OTHER
Gundersen Health System
OTHER
Wake Forest University Health Sciences
OTHER
Oregon Health and Science University
OTHER
Medical College of Wisconsin
OTHER
Temple University
OTHER
New Jersey Medical School
OTHER
University of South Alabama
OTHER
Vanderbilt University
OTHER
University of Arkansas
OTHER
Emory University
OTHER
St. Luke's Hospital and Health Network, Pennsylvania
OTHER
The Cleveland Clinic
OTHER
University of Tennessee
OTHER
TriHealth Inc.
OTHER
Tulane University
OTHER
Yale University
OTHER
Arrowhead Regional Medical Center
OTHER
Geisinger Clinic
OTHER
Miami Valley Hospital
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Alan Tita
Principal Investigator
Principal Investigators
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Alan Tita, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham - Clinical Coordinating Center
Gary Cutter, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham-Data Coordinating Center
Jeff Szychowski, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham-Data Coordinating Center
Locations
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University of Alabama at Birmingham, Clinical Coordinating Center
Birmingham, Alabama, United States
University of Alabama at Birmingham, Data Coordinating Center
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Arrowhead Regional Medical Center
Colton, California, 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
Stanford University
Stanford, California, United States
University of Colorado
Boulder, Colorado, United States
Denver Health
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Christiana Care Health Services
Newark, Delaware, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern
Evanston, Illinois, United States
Indiana University
Bloomington, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Lawrence, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Tulane
New Orleans, Louisiana, United States
Ochsner Health System/Medical Center
New Orleans, Louisiana, United States
Beaumont Hospital
Royal Oak, Michigan, United States
University of Mississippi Medical College
Jackson, Mississippi, United States
Washington University
St Louis, Missouri, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
St. Peters University Hospital
New Brunswick, New Jersey, United States
New Jersey Medical School
Newark, New Jersey, United States
Virtua Medical Group
Sewell, New Jersey, United States
New York Presbyterian Queens
Flushing, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Columbia University
New York, New York, United States
Weill Cornell
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke Regional Medical Center
Durham, North Carolina, United States
Duke University
Durham, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
TriHealth, Inc
Cincinnati, Ohio, United States
Case Western/Metro Health
Cleveland, Ohio, United States
Cleveland Clinic Fairview
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Cleveland Clinic-Hillcrest Hospital
Mayfield Heights, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Lehigh Valley Hospital/Health Network
Allentown, Pennsylvania, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Geisinger Clinic
Danville, Pennsylvania, 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
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburg/Magee Women's Center
Pittsburgh, Pennsylvania, United States
Brown (WIHRI)
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
UT Southwestern
Dallas, Texas, United States
UT Medical Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
UT Houston
Houston, Texas, United States
McKay Dee Hospital
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Unity Point Health-Meriter Hospital
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aurora Research Institute
Milwaukee, Wisconsin, United States
Countries
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References
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Sanusi AA, Leach J, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson KS, Haas DM, Plante L, Metz TD, Casey B, Esplin S, Longo S, Hoffman MK, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Su EJ, Krishna I, Nguyen NA, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Geller NL, Kuo HC, Sinkey RG, Librizzi R, Pereira L, Magann EF, Habli M, Williams S, Mari G, Pridjian G, McKenna DS, Parrish M, Eugene Chang, Osmundson S, Quinones J, Szychowski JM, Tita ATN. Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension. Obstet Gynecol. 2024 Jul 1;144(1):126-134. doi: 10.1097/AOG.0000000000005613. Epub 2024 May 23.
Moore MD, Kuo HC, Sinkey RG, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson KS, Haas DM, Plante L, Metz TD, Casey B, Esplin S, Longo S, Hoffman MK, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey HA, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su EJ, Krishna I, Nguyen NA, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Librizzi R, Pereira L, Magann EF, Habli M, Williams S, Mari G, Pridjian G, McKenna DS, Parrish M, Chang E, Osmundson S, Quinones JN, Leach J, Sanusi A, Galis ZS, Harper L, Ambalavanan N, Szychowski JM, Tita ATN. Mean Arterial Pressure and Neonatal Outcomes in Pregnancies Complicated by Mild Chronic Hypertension. Obstet Gynecol. 2024 Jul 1;144(1):101-108. doi: 10.1097/AOG.0000000000005611. Epub 2024 May 23.
Bailey EJ, Tita ATN, Leach J, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson K, Haas DM, Plante L, Metz TD, Casey BM, Esplin S, Longo S, Hoffman M, Saade GR, Foroutan J, Tuuli MG, Owens MY, Simhan HN, Frey HA, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su EJ, Krishna I, Nguyen N, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Oparil S, Kuo HC, Szychowski JM, Hoppe K. Perinatal Outcomes Associated With Management of Stage 1 Hypertension. Obstet Gynecol. 2023 Dec 1;142(6):1395-1404. doi: 10.1097/AOG.0000000000005410. Epub 2023 Sep 28.
Goulding AN, Antoniewicz L, Leach JM, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Edwards RK, Gibson K, Haas DM, Plante L, Metz TD, Casey B, Esplin S, Longo S, Hoffman M, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, Reddy UM, Kinzler W, Su E, Krishna I, Nguyen N, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Harper LM, Ambalavanan N, Oparil S, Szychowski JM, Tita AT; Chronic Hypertension and Pregnancy Trial Consortium. Breastfeeding initiation and duration among people with mild chronic hypertension: a secondary analysis of the Chronic Hypertension and Pregnancy trial. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101086. doi: 10.1016/j.ajogmf.2023.101086. Epub 2023 Jul 10.
Tita AT, Szychowski JM, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson K, Haas DM, Plante L, Metz T, Casey B, Esplin S, Longo S, Hoffman M, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su E, Krishna I, Nguyen N, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Geller NL, Oparil S, Cutter GR, Andrews WW; Chronic Hypertension and Pregnancy (CHAP) Trial Consortium. Treatment for Mild Chronic Hypertension during Pregnancy. N Engl J Med. 2022 May 12;386(19):1781-1792. doi: 10.1056/NEJMoa2201295. Epub 2022 Apr 2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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