Treatment for Mild Chronic Hypertension during Pregnancy
Copyright © 2022 Massachusetts Medical Society..
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.).
| Errataetall: |
CommentIn: N Engl J Med. 2022 May 12;386(19):1846-1847. - PMID 35363952 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:386 |
|---|---|
| Enthalten in: |
The New England journal of medicine - 386(2022), 19 vom: 12. Mai, Seite 1781-1792 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Tita, Alan T [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antihypertensive Agents |
|---|
| Anmerkungen: |
Date Completed 17.05.2022 Date Revised 17.06.2023 published: Print-Electronic ClinicalTrials.gov: NCT02299414 CommentIn: N Engl J Med. 2022 May 12;386(19):1846-1847. - PMID 35363952 Citation Status MEDLINE |
|---|
| doi: |
10.1056/NEJMoa2201295 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM33893863X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM33893863X | ||
| 003 | DE-627 | ||
| 005 | 20231226001806.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1056/NEJMoa2201295 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1129.xml |
| 035 | |a (DE-627)NLM33893863X | ||
| 035 | |a (NLM)35363951 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Tita, Alan T |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Treatment for Mild Chronic Hypertension during Pregnancy |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 17.05.2022 | ||
| 500 | |a Date Revised 17.06.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02299414 | ||
| 500 | |a CommentIn: N Engl J Med. 2022 May 12;386(19):1846-1847. - PMID 35363952 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 Massachusetts Medical Society. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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.) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Antihypertensive Agents |2 NLM | |
| 700 | 1 | |a Szychowski, Jeff M |e verfasserin |4 aut | |
| 700 | 1 | |a Boggess, Kim |e verfasserin |4 aut | |
| 700 | 1 | |a Dugoff, Lorraine |e verfasserin |4 aut | |
| 700 | 1 | |a Sibai, Baha |e verfasserin |4 aut | |
| 700 | 1 | |a Lawrence, Kirsten |e verfasserin |4 aut | |
| 700 | 1 | |a Hughes, Brenna L |e verfasserin |4 aut | |
| 700 | 1 | |a Bell, Joseph |e verfasserin |4 aut | |
| 700 | 1 | |a Aagaard, Kjersti |e verfasserin |4 aut | |
| 700 | 1 | |a Edwards, Rodney K |e verfasserin |4 aut | |
| 700 | 1 | |a Gibson, Kelly |e verfasserin |4 aut | |
| 700 | 1 | |a Haas, David M |e verfasserin |4 aut | |
| 700 | 1 | |a Plante, Lauren |e verfasserin |4 aut | |
| 700 | 1 | |a Metz, Torri |e verfasserin |4 aut | |
| 700 | 1 | |a Casey, Brian |e verfasserin |4 aut | |
| 700 | 1 | |a Esplin, Sean |e verfasserin |4 aut | |
| 700 | 1 | |a Longo, Sherri |e verfasserin |4 aut | |
| 700 | 1 | |a Hoffman, Matthew |e verfasserin |4 aut | |
| 700 | 1 | |a Saade, George R |e verfasserin |4 aut | |
| 700 | 1 | |a Hoppe, Kara K |e verfasserin |4 aut | |
| 700 | 1 | |a Foroutan, Janelle |e verfasserin |4 aut | |
| 700 | 1 | |a Tuuli, Methodius |e verfasserin |4 aut | |
| 700 | 1 | |a Owens, Michelle Y |e verfasserin |4 aut | |
| 700 | 1 | |a Simhan, Hyagriv N |e verfasserin |4 aut | |
| 700 | 1 | |a Frey, Heather |e verfasserin |4 aut | |
| 700 | 1 | |a Rosen, Todd |e verfasserin |4 aut | |
| 700 | 1 | |a Palatnik, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Baker, Susan |e verfasserin |4 aut | |
| 700 | 1 | |a August, Phyllis |e verfasserin |4 aut | |
| 700 | 1 | |a Reddy, Uma M |e verfasserin |4 aut | |
| 700 | 1 | |a Kinzler, Wendy |e verfasserin |4 aut | |
| 700 | 1 | |a Su, Emily |e verfasserin |4 aut | |
| 700 | 1 | |a Krishna, Iris |e verfasserin |4 aut | |
| 700 | 1 | |a Nguyen, Nicki |e verfasserin |4 aut | |
| 700 | 1 | |a Norton, Mary E |e verfasserin |4 aut | |
| 700 | 1 | |a Skupski, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a El-Sayed, Yasser Y |e verfasserin |4 aut | |
| 700 | 1 | |a Ogunyemi, Dotum |e verfasserin |4 aut | |
| 700 | 1 | |a Galis, Zorina S |e verfasserin |4 aut | |
| 700 | 1 | |a Harper, Lorie |e verfasserin |4 aut | |
| 700 | 1 | |a Ambalavanan, Namasivayam |e verfasserin |4 aut | |
| 700 | 1 | |a Geller, Nancy L |e verfasserin |4 aut | |
| 700 | 1 | |a Oparil, Suzanne |e verfasserin |4 aut | |
| 700 | 1 | |a Cutter, Gary R |e verfasserin |4 aut | |
| 700 | 1 | |a Andrews, William W |e verfasserin |4 aut | |
| 700 | 0 | |a Chronic Hypertension and Pregnancy (CHAP) Trial Consortium |e verfasserin |4 aut | |
| 700 | 1 | |a Beamon, Carmen |e investigator |4 oth | |
| 700 | 1 | |a Librizzi, Ronald |e investigator |4 oth | |
| 700 | 1 | |a Pereira, Leonardo |e investigator |4 oth | |
| 700 | 1 | |a Magann, Everett F |e investigator |4 oth | |
| 700 | 1 | |a Habli, Mounira |e investigator |4 oth | |
| 700 | 1 | |a Williams, Shauna |e investigator |4 oth | |
| 700 | 1 | |a Mari, Giancarlo |e investigator |4 oth | |
| 700 | 1 | |a Pridjian, Gabriella |e investigator |4 oth | |
| 700 | 1 | |a McKenna, David S |e investigator |4 oth | |
| 700 | 1 | |a Parrish, Marc |e investigator |4 oth | |
| 700 | 1 | |a Chang, Eugene |e investigator |4 oth | |
| 700 | 1 | |a Osmundson, Sarah |e investigator |4 oth | |
| 700 | 1 | |a Quinones, JoAnne |e investigator |4 oth | |
| 700 | 1 | |a Perni, Uma |e investigator |4 oth | |
| 700 | 1 | |a Wapner, Ronald |e investigator |4 oth | |
| 700 | 1 | |a Booker, Whitney |e investigator |4 oth | |
| 700 | 1 | |a Murtha, Amy P |e investigator |4 oth | |
| 700 | 1 | |a Chien, Ed |e investigator |4 oth | |
| 700 | 1 | |a Varner, Michael |e investigator |4 oth | |
| 700 | 1 | |a Wells, C Edward |e investigator |4 oth | |
| 700 | 1 | |a Biggio, Joseph |e investigator |4 oth | |
| 700 | 1 | |a Nagvi, Fatima |e investigator |4 oth | |
| 700 | 1 | |a Macones, George A |e investigator |4 oth | |
| 700 | 1 | |a Stout, Molly |e investigator |4 oth | |
| 700 | 1 | |a Carter, Ebony |e investigator |4 oth | |
| 700 | 1 | |a Lipkind, Heather |e investigator |4 oth | |
| 700 | 1 | |a Roloff, Kristina |e investigator |4 oth | |
| 700 | 1 | |a Dudley, Donald J |e investigator |4 oth | |
| 700 | 1 | |a Heller, Glenn |e investigator |4 oth | |
| 700 | 1 | |a Roberson, Paula K |e investigator |4 oth | |
| 700 | 1 | |a Shankaran, Seetha |e investigator |4 oth | |
| 700 | 1 | |a Wachbroit, Robert |e investigator |4 oth | |
| 700 | 1 | |a Hauth, John C |e investigator |4 oth | |
| 700 | 1 | |a Subramaniam, Akila |e investigator |4 oth | |
| 700 | 1 | |a LeDuke, Rachel |e investigator |4 oth | |
| 700 | 1 | |a Grant, Janatha |e investigator |4 oth | |
| 700 | 1 | |a Hill, Tawanda |e investigator |4 oth | |
| 700 | 1 | |a Boyd, Amber |e investigator |4 oth | |
| 700 | 1 | |a Dimperio, Lisa |e investigator |4 oth | |
| 700 | 1 | |a Corley-Topham, Glenda |e investigator |4 oth | |
| 700 | 1 | |a Feese, Michelle L |e investigator |4 oth | |
| 700 | 1 | |a Parks, Robin W |e investigator |4 oth | |
| 700 | 1 | |a Steele, Robin |e investigator |4 oth | |
| 700 | 1 | |a Kuo, Hui-Chien |e investigator |4 oth | |
| 700 | 1 | |a Orange, Yukiko N |e investigator |4 oth | |
| 700 | 1 | |a Parks, Christopher |e investigator |4 oth | |
| 700 | 1 | |a Dorman, Karen |e investigator |4 oth | |
| 700 | 1 | |a Pena, Kathia |e investigator |4 oth | |
| 700 | 1 | |a Stock, Janet |e investigator |4 oth | |
| 700 | 1 | |a Norton, Beth |e investigator |4 oth | |
| 700 | 1 | |a Murphy, Samantha |e investigator |4 oth | |
| 700 | 1 | |a Muzzarelli, Lucia |e investigator |4 oth | |
| 700 | 1 | |a Blackwell, Sean C |e investigator |4 oth | |
| 700 | 1 | |a Chahine, Khalil M |e investigator |4 oth | |
| 700 | 1 | |a Tounsi, Sarah |e investigator |4 oth | |
| 700 | 1 | |a Lucci, Joseph |c 4th |e investigator |4 oth | |
| 700 | 1 | |a Hutchinson, Maria |e investigator |4 oth | |
| 700 | 1 | |a Lynch, Stephanie |e investigator |4 oth | |
| 700 | 1 | |a Torres, Caroline |e investigator |4 oth | |
| 700 | 1 | |a Kalemi, Luiza |e investigator |4 oth | |
| 700 | 1 | |a Swamy, Geeta K |e investigator |4 oth | |
| 700 | 1 | |a Ferrara, Jennifer |e investigator |4 oth | |
| 700 | 1 | |a Lanpher, Danielle |e investigator |4 oth | |
| 700 | 1 | |a O'Berry, Amy |e investigator |4 oth | |
| 700 | 1 | |a Weaver, Kristin |e investigator |4 oth | |
| 700 | 1 | |a Parsons, Thomas |e investigator |4 oth | |
| 700 | 1 | |a Hahn, Susan |e investigator |4 oth | |
| 700 | 1 | |a Clement, Margaret |e investigator |4 oth | |
| 700 | 1 | |a Zighelboim, Israel |e investigator |4 oth | |
| 700 | 1 | |a Tolosa, Jorge |e investigator |4 oth | |
| 700 | 1 | |a Juarez, Almaguer |e investigator |4 oth | |
| 700 | 1 | |a Munoz Beilis, Melissa |e investigator |4 oth | |
| 700 | 1 | |a Chen, Jia |e investigator |4 oth | |
| 700 | 1 | |a Zaragoza Zapian, Jorge |e investigator |4 oth | |
| 700 | 1 | |a Ostovar-Kermani, Tiffany |e investigator |4 oth | |
| 700 | 1 | |a Bisbal, Zaida |e investigator |4 oth | |
| 700 | 1 | |a Standerfer, Elizabeth |e investigator |4 oth | |
| 700 | 1 | |a Zornes, Christina |e investigator |4 oth | |
| 700 | 1 | |a Woods, Kyra |e investigator |4 oth | |
| 700 | 1 | |a Brinkman, Alyson |e investigator |4 oth | |
| 700 | 1 | |a Trent, Jennifer |e investigator |4 oth | |
| 700 | 1 | |a Polito, LuAnn |e investigator |4 oth | |
| 700 | 1 | |a Rouse, Caroline |e investigator |4 oth | |
| 700 | 1 | |a Wilson, Jennifer |e investigator |4 oth | |
| 700 | 1 | |a Dickerson, Heather |e investigator |4 oth | |
| 700 | 1 | |a Barnes, Shannon |e investigator |4 oth | |
| 700 | 1 | |a Shockley, Hannah |e investigator |4 oth | |
| 700 | 1 | |a Firman, Brandy |e investigator |4 oth | |
| 700 | 1 | |a Tocci, Cheryl |e investigator |4 oth | |
| 700 | 1 | |a Sowles, Amber |e investigator |4 oth | |
| 700 | 1 | |a Hill, Kim |e investigator |4 oth | |
| 700 | 1 | |a Lamb, Denise |e investigator |4 oth | |
| 700 | 1 | |a Moseley, Lisa |e investigator |4 oth | |
| 700 | 1 | |a Meadows, Catherine |e investigator |4 oth | |
| 700 | 1 | |a Dellermann, Sandi |e investigator |4 oth | |
| 700 | 1 | |a Servay, Chris |e investigator |4 oth | |
| 700 | 1 | |a Garvey, Cathryn |e investigator |4 oth | |
| 700 | 1 | |a Arias, Kathleen |e investigator |4 oth | |
| 700 | 1 | |a Hendricks, Melissa |e investigator |4 oth | |
| 700 | 1 | |a Ruhstaller, Kelly |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t The New England journal of medicine |d 1945 |g 386(2022), 19 vom: 12. Mai, Seite 1781-1792 |w (DE-627)NLM000008184 |x 1533-4406 |7 nnns |
| 773 | 1 | 8 | |g volume:386 |g year:2022 |g number:19 |g day:12 |g month:05 |g pages:1781-1792 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1056/NEJMoa2201295 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 386 |j 2022 |e 19 |b 12 |c 05 |h 1781-1792 | ||