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 - Funding Information:
The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute, the National Institutes of Health, or the Department of Health and Human Services. Supported by the National Heart, Lung, and Blood Institute. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
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.).
UR - http://www.scopus.com/inward/record.url?scp=85128947159&partnerID=8YFLogxK
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 -