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Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension. 2024
Ayodeji A Sanusi, and
Justin Leach, and
Kim Boggess, and
Lorraine Dugoff, and
Baha Sibai, and
Kirsten Lawrence, and
Brenna L Hughes, and
Joseph Bell, and
Kjersti Aagaard, and
Rodney K Edwards, and
Kelly S Gibson, and
David M Haas, and
Lauren Plante, and
Torri D Metz, and
Brian Casey, and
Sean Esplin, and
Sherri Longo, and
Matthew K Hoffman, and
George R Saade, and
Kara K Hoppe, and
Janelle Foroutan, and
Methodius Tuuli, and
Michelle Y Owens, and
Hyagriv N Simhan, and
Heather Frey, and
Todd Rosen, and
Anna Palatnik, and
Susan Baker, and
Phyllis August, and
Uma M Reddy, and
Emily J Su, and
Iris Krishna, and
Nguyet A Nguyen, and
Mary E Norton, and
Daniel Skupski, and
Yasser Y El-Sayed, and
Dotun Ogunyemi, and
Zorina S Galis, and
Lorie Harper, and
Namasivayam Ambalavanan, and
Nancy L Geller, and
Hui-Chien Kuo, and
Rachel G Sinkey, and
Ronald Librizzi, and
Leonardo Pereira, and
Everett F Magann, and
Mounira Habli, and
Shauna Williams, and
Giancarlo Mari, and
Gabriella Pridjian, and
David S McKenna, and
Marc Parrish, and
Eugene Chang, and
Sarah Osmundson, and
JoAnne Quinones, and
Jeff M Szychowski, and
Alan T N Tita
Departments of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, and University of South Alabama at Mobile, Mobile, Alabama, University of North Carolina at Chapel Hill, Chapel Hill, and Duke University, Durham, North Carolina, University of Pennsylvania and Drexel University College of Medicine, Philadelphia, and Magee Women's Hospital and University of Pittsburgh, Pittsburgh, Pennsylvania, University of Texas at Houston and the Division of Maternal-Fetal Medicine, Baylor College of Medicine and Texas Children's Hospital, Houston, and University of Texas Medical Branch, Galveston, Texas, Columbia University and Weill Cornell University, New York, and New York Presbyterian Queens Hospital, Flushing, New York, University of Oklahoma Health Sciences, Oklahoma City, Oklahoma, Indiana University, Indianapolis, Indiana, University of Utah and Intermountain Healthcare, Salt Lake City, Utah, UnityPoint Health-Meriter Hospital/Marshfield Clinic, Madison, Wisconsin, Washington University in St. Louis, St. Louis, Missouri, University of Mississippi Medical Center, Jackson, Mississippi, The Ohio State University, Columbus, Ohio, Rutgers University-Robert Wood Johnson Medical School, New Brunswick, New Jersey, Medical College of Wisconsin, Milwaukee, Wisconsin, Yale University, New Haven, Connecticut, University of Colorado, Aurora, and Denver Health, Denver, Colorado, Emory University, Atlanta, Georgia.
OBJECTIVE To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial. METHODS We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding. RESULTS Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine. CONCLUSIONS No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy. BACKGROUND ClinicalTrials.gov, NCT02299414.
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