TY - JOUR
T1 - Treatment for Mild Chronic Hypertension during Pregnancy
AU - Chronic Hypertension and Pregnancy (CHAP) Trial Consortium
AU - Tita, Alan T.
AU - Szychowski, Jeff M.
AU - Boggess, Kim
AU - Dugoff, Lorraine
AU - Sibai, Baha
AU - Lawrence, Kirsten
AU - Hughes, Brenna L.
AU - Bell, Joseph
AU - Aagaard, Kjersti
AU - Edwards, Rodney K.
AU - Gibson, Kelly
AU - Haas, David M.
AU - Plante, Lauren
AU - Metz, Torri
AU - Casey, Brian
AU - Esplin, Sean
AU - Longo, Sherri
AU - Hoffman, Matthew
AU - Saade, George R.
AU - Hoppe, Kara K.
AU - Foroutan, Janelle
AU - Tuuli, Methodius
AU - Owens, Michelle Y.
AU - Simhan, Hyagriv N.
AU - Frey, Heather
AU - Rosen, Todd
AU - Palatnik, Anna
AU - Baker, Susan
AU - August, Phyllis
AU - Reddy, Uma M.
AU - Kinzler, Wendy
AU - Su, Emily
AU - Krishna, Iris
AU - Nguyen, Nicki
AU - Norton, Mary E.
AU - Skupski, Daniel
AU - El-Sayed, Yasser Y.
AU - Ogunyemi, Dotum
AU - Galis, Zorina S.
AU - Harper, Lorie
AU - Ambalavanan, Namasivayam
AU - Geller, Nancy L.
AU - Oparil, Suzanne
AU - Cutter, Gary R.
AU - Andrews, William W.
N1 - Publisher Copyright:
© 2022 Massachusetts Medical Society.
PY - 2022/5/12
Y1 - 2022/5/12
N2 - 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-forgestational- 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.).
AB - 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-forgestational- 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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U2 - 10.1056/NEJMoa2201295
DO - 10.1056/NEJMoa2201295
M3 - Article
C2 - 35363951
AN - SCOPUS:85128947159
SN - 0028-4793
VL - 386
SP - 1781
EP - 1792
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 19
ER -