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Cited by 567Pregnancy and preeclampsia studiesPregnancy and Medication ImpactNeurological Complications and Syndromes

Treatment for mild chronic hypertension during pregnancy

Open access
Tita, Alan T., Szychowski, Jeff M., Boggess, Kim, Dugoff, Lorraine, Sibai, Baha, Lawrence, Kirsten, Hughes, Brenna L., Bell, Joseph +37 more·2022·New England Journal of Medicine
DOI 10.1056/nejmoa2201295PMC PMC9575330
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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.).

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  • In the CHAP trial, attained mean systolic blood pressure was 129.5 ± 10.0 vs. 132.6 ± 10.1 mmHg and diastolic was 79.1 ± 7.4 vs. 81.5 ± 8.0 mmHg in treated versus untreated groups.

    “Attained mean ± SD blood pressure measurements in the treated versus untreated groups were systolic 129.5 ± 10.0 vs. 132.6 ± 10.1 mmHg (betweengroup difference À3.11 [95% CI À3.95 to 2.28]) and diastolic 79.1 ± 7.4 vs. 81.5 ± 8.0 mmHg (À2.33 [95% CI À2.97 to 0.04]) (123).”

    From 15. Management of Diabetes in Pregnancy: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [123]

    The Results (Medication Adherence) report the stated systolic and diastolic means for the active-treatment and control groups. Our copy does not give the standard deviations stated in the claim or the exact confidence intervals printed in the citing sentence, so those details cannot be verified from this source. (LLM, conf=0.86)

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  • The CHAP Consortium's study mitigates concerns about small-for-gestational-age birth weight.

    “The CHAP Consortium's study mitigates concerns about small-for-gestational-age birth weight.”

    From 15. Management of Diabetes in Pregnancy: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [123]

  • The CHAP Trial Consortium's RCT demonstrated that a blood pressure of 140/90 mmHg as the threshold for initiation or titration of treatment reduces the incidence of adverse pregnancy outcomes without compromising fetal growth.

    “The Chronic Hypertension and Pregnancy (CHAP) Trial Consortium's RCT on treatment for mild chronic hypertension during pregnancy demonstrated that a blood pressure of 140/90 mmHg, as the threshold for initiation or titration of treatment, reduces the incidence of adverse pregnancy outcomes without compromising fetal growth (123).”

    From 15. Management of Diabetes in Pregnancy: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [123]

  • In CHAP, the primary outcome, a composite of preeclampsia with severe features, medically indicated preterm birth at <35 weeks of gestation, placental abruption, or fetal or neonatal death, occurred in 30.2% of female participants in the active treatment group versus 37.0% in the control group (P < 0.001).

    “The primary outcome, a composite of preeclampsia with severe features, medically indicated preterm birth at <35 weeks of gestation, placental abruption, or fetal or neonatal death, occurred in 30.2% of female participants in the active treatment group versus 37.0% in the control group (P < 0.001).”

    From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [55]

  • In the CHAP trial, individuals with diabetes had an even better composite outcome score than those without diabetes.

    “Individuals with diabetes had an even better composite outcome score than those without diabetes (123).”

    From 15. Management of Diabetes in Pregnancy: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [123]

    The Methods (Outcomes; page unavailable) list diabetes status as a prespecified subgroup for the composite primary outcome. The Results (Subgroup Analyses; page unavailable) say subgroup treatment-effect confidence intervals were consistent with the overall result, but our copy gives no comparison showing a better composite outcome for participants with diabetes than for those without it. Searched for diabetes and the subgroup comparison. (LLM, conf=0.72)

    Experimental — accuracy not yet measured

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Authors
Tita, A. T., Szychowski, J. M., Boggess, K., Dugoff, L., Sibai, B., Lawrence, K., Hughes, B. L., Bell, J., Aagaard, K., Edwards, R. K., Gibson, K., Haas, D. M., Plante, L., Metz, T., Casey, B., Esplin, S., Longo, S., Hoffman, M., Saade, G. R., Hoppe, K. K., Foroutan, J., Tuuli, M., Owens, M. Y., Simhan, H. N., Frey, H., Rosen, T., Palatnik, A., Baker, S., August, P., Reddy, U. M., Kinzler, W., Su, E., Krishna, I., Nguyen, N., Norton, M. E., Skupski, D., El-Sayed, Y. Y., Ogunyemi, D., Galis, Z. S., Harper, L., Ambalavanan, N., Geller, N. L., Oparil, S., Cutter, G. R., & Andrews, W. W.
Affiliations
  • University of Alabama (US)
  • University of North Carolina at Chapel Hill (US)
  • Duke University (US)
  • St. Luke's University Health Network (US)
  • MetroHealth (US)
  • Intermountain Healthcare (US)
  • Marshfield Clinic (US)
  • Saint Peter's University Hospital (US)
  • University of Pittsburgh (US)
  • Rutgers, The State University of New Jersey (US)
  • Winthrop-University Hospital (US)
  • Emory University (US)
  • San Francisco General Hospital (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2022-05-12
Volume
386
Issue
19
Pages
1781-1792
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2201295
PMC
PMC9575330
OpenAlex
W4226033627
Cited by
567
References
25
Citations by year
2026: 107 · 2025: 123 · 2024: 132 · 2023: 130 · 2022: 75
FWCI
115.38
Type
journal article
Language
en
Open access
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • IUScholarWorks (Indiana University) (submittedVersion)
  • Digital Commons-TMC (Texas Medical Center) (submittedVersion)
  • Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
Funders
The National Heart Lung and Blood Institute (5U01HL119242, 5U01HL120338)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Pregnancy and preeclampsia studies
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
  • Health Sciences › Medicine › Psychiatry and Mental health › Neurological Complications and Syndromes
Keywords
chronic hypertension in pregnancy, antihypertensive therapy, blood pressure targets, preeclampsia, preterm birth, placental abruption, fetal growth restriction, neonatal complications, maternal complications, adverse pregnancy outcomes, singleton pregnancy, severe hypertension in pregnancy
MeSH terms
Abruptio Placentae, Antihypertensive Agents, Birth Weight, Chronic Disease, Female, Fetal Growth Retardation, Humans, Hypertension, Infant, Newborn, Pre-Eclampsia, Pregnancy, Pregnancy Outcome, Hypertension, Pregnancy-Induced, Premature Birth

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