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Treatment for Mild Chronic Hypertension during Pregnancy
- Tita, Alan T;
- Szychowski, Jeff M;
- Boggess, Kim;
- Dugoff, Lorraine;
- Sibai, Baha;
- Lawrence, Kirsten;
- Hughes, Brenna L;
- Bell, Joseph;
- Aagaard, Kjersti;
- Edwards, Rodney K;
- Gibson, Kelly;
- Haas, David M;
- Plante, Lauren;
- Metz, Torri;
- Casey, Brian;
- Esplin, Sean;
- Longo, Sherri;
- Hoffman, Matthew;
- Saade, George R;
- Hoppe, Kara K;
- Foroutan, Janelle;
- Tuuli, Methodius;
- Owens, Michelle Y;
- Simhan, Hyagriv N;
- Frey, Heather;
- Rosen, Todd;
- Palatnik, Anna;
- Baker, Susan;
- August, Phyllis;
- Reddy, Uma M;
- Kinzler, Wendy;
- Su, Emily;
- Krishna, Iris;
- Nguyen, Nicki;
- Norton, Mary E;
- Skupski, Daniel;
- El-Sayed, Yasser Y;
- Ogunyemi, Dotum;
- Galis, Zorina S;
- Harper, Lorie;
- Ambalavanan, Namasivayam;
- Geller, Nancy L;
- Oparil, Suzanne;
- Cutter, Gary R;
- Andrews, William W
Published Web Location
https://doi.org/10.1056/nejmoa2201295Abstract
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.).Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.