drugset / Trial / NCT02299414
Chronic Hypertension and Pregnancy (CHAP) Project
Phase 4
Completed
2408 enrolled
University of Alabama at Birmingham
Arrowhead Regional Medical Center · collabBaylor College of Medicine · collabBeaumont Hospital · collabCase Western/Metro Health · collabChristiana Care Health Services · collabColumbia University · collabDenver Health and Hospital Authority · collabDrexel University College of Medicine · collabDuke Regional Hospital · collabDuke University · collabEmory University · collabGeisinger Clinic · collabGundersen Health System · collabIndiana University · collabIntermountain Health Care, Inc. · collabJohns Hopkins University · collabLatter Day Saints Hospital · collabLehigh Valley Hospital · collabLyndon B Johnson General Hospital · collabMcKay-Dee Hospital · collabMedical College of Wisconsin · collabMedical University of South Carolina · collabMeriter Foundation · collabMiami Valley Hospital · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabNew Jersey Medical School · collabNew York Hospital Queens · collabNorthwestern University · collabOchsner Health System · collabOhio State University · collabOregon Health and Science University · collabRutgers, The State University of New Jersey · collabSaint Peters University Hospital · collabSan Francisco General Hospital · collabSt. Luke's Hospital and Health Network, Pennsylvania · collabStanford University · collabTemple University · collabThe Cleveland Clinic · collabThe University of Texas Health Science Center, Houston · collabThe University of Texas Medical Branch, Galveston · collabTriHealth Inc. · collabTulane University · collabUniversity of Arkansas · collabUniversity of California, San Diego · collabUniversity of California, San Francisco · collabUniversity of Colorado, Denver · collabUniversity of Iowa · collabUniversity of Kansas Medical Center · collabUniversity of North Carolina, Chapel Hill · collabUniversity of Oklahoma · collabUniversity of Pennsylvania · collabUniversity of Pittsburgh · collabUniversity of South Alabama · collabUniversity of Tennessee · collabUniversity of Texas Southwestern Medical Center · collabUniversity of Utah · collabUtah Valley Regional Medical Center · collabVanderbilt University · collabVirtua Medical Group · collabWake Forest University Health Sciences · collabWakeMed Health and Hospitals · collabWashington University School of Medicine · collabWeill Medical College of Cornell University · collabWinthrop University Hospital · collabWomen and Infants Hospital of Rhode Island · collabYale University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-06
- Primary completion
- 2022-04-01
- Completion
- 2022-12-16
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Labetalol | Small molecule | — | Oral |
| Subject | Nifedipine | Other / unclassified | — | Oral |