Alan T Tita1, Jeff M Szychowski1, Kim Boggess1, Lorraine Dugoff1, Baha Sibai1, Kirsten Lawrence1, Brenna L Hughes1, Joseph Bell1, Kjersti Aagaard1, Rodney K Edwards1, Kelly Gibson1, David M Haas1, Lauren Plante1, Torri Metz1, Brian Casey1, Sean Esplin1, Sherri Longo1, Matthew Hoffman1, George R Saade1, Kara K Hoppe1, Janelle Foroutan1, Methodius Tuuli1, Michelle Y Owens1, Hyagriv N Simhan1, Heather Frey1, Todd Rosen1, Anna Palatnik1, Susan Baker1, Phyllis August1, Uma M Reddy1, Wendy Kinzler1, Emily Su1, Iris Krishna1, Nicki Nguyen1, Mary E Norton1, Daniel Skupski1, Yasser Y El-Sayed1, Dotum Ogunyemi1, Zorina S Galis1, Lorie Harper1, Namasivayam Ambalavanan1, Nancy L Geller1, Suzanne Oparil1, Gary R Cutter1, William W Andrews1. 1. From the Department of Obstetrics and Gynecology (A.T.T., W.W.A.), the Center for Women's Reproductive Health (A.T.T., J.M.S., N.A., S.O., G.R.C., W.W.A.), the Department of Biostatistics (J.M.S., G.R.C.), the Division of Neonatology, Department of Pediatrics (N.A.), and the Division of Cardiovascular Disease, Department of Medicine (S.O.), University of Alabama, Birmingham; the Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill (K.B.), and the Department of Obstetrics and Gynecology, Duke University, Durham (B.L.H.) - both in North Carolina; the Department of Obstetrics and Gynecology, University of Pennsylvania (L.D.), and the Department of Obstetrics and Gynecology, Drexel University College of Medicine (L.P.), Philadelphia, St. Luke's University Health Network, Fountain Hill (J.B.), and the Department of Obstetrics and Gynecology, Magee Women's Hospital, University of Pittsburgh, Pittsburgh (H.N.S.) - all in Pennsylvania; the Department of Obstetrics and Gynecology, University of Texas (B.S.), and the Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, Houston (K.A.), the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas (B.C.), the Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston (G.R.S.), and the Department of Women's Health, University of Texas, Austin (L.H.); the Department of Obstetrics and Gynecology, Columbia University (K.L.), Weill Cornell University (P.A.), and the Department of Obstetrics and Gynecology, New York Presbyterian Queens Hospital (D.S.), New York, and the Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola (W.K.) - all in New York; the Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences, Oklahoma City (R.K.E.); MetroHealth System, Cleveland (K.G.); the Department of Obstetrics and Gynecology, Indiana University, Indianapolis (D.M.H.); the Department of Obstetrics and Gynecology, University of Utah (T.M.), and Intermountain Healthcare (S.E.), Salt Lake City; Ochsner Baptist Medical Center, New Orleans (S.L.); Christiana Care Health Services, Newark, DE (M.H.); the Department of Obstetrics and Gynecology, UnityPoint Health-Meriter Hospital/Marshfield Clinic, Madison (K.K.H.), and the Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee (A.P.); St. Peters University Hospital (J.F.) and the Department of Obstetrics and Gynecology, Robert Wood Johnson Medical School, Rutgers University (T.R.), New Brunswick, NJ; the Department of Obstetrics and Gynecology, Washington University, St. Louis (M.T.); the Department of Obstetrics and Gynecology, University of Mississippi Medical Center, Jackson (M.Y.O.); the Department of Obstetrics and Gynecology, Ohio State University, Columbus (H.F.); the Department of Obstetrics and Gynecology, University of South Alabama, Mobile (S.B.); the Department of Obstetrics and Gynecology, Yale University, New Haven, CT (U.M.R.); the Department of Obstetrics and Gynecology, University of Colorado, Boulder (E.S.), and the Department of Obstetrics and Gynecology, Denver Health, Denver (N.N.); the Department of Obstetrics and Gynecology, Emory University, Atlanta (I.K.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital (M.E.N.), San Francisco, the Department of Obstetrics and Gynecology, Stanford University, Stanford (Y.Y.E.-S.), and the Department of Obstetrics and Gynecology, Arrowhead Regional Medical Center, Colton (D.O.); Beaumont Hospital, Southfield, MI (D.O.); and the Division of Cardiovascular Sciences (Z.S.G.) and the Office of Biostatistics Research (N.L.G.), National Heart, Lung, and Blood Institute, Bethesda, MD.
Abstract
BACKGROUND: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth. METHODS: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth. RESULTS: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99). CONCLUSIONS: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.).
BACKGROUND: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth. METHODS: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth. RESULTS: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99). CONCLUSIONS: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.).
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