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Tight Versus Liberal Control of Mild Postpartum Hypertension: A Randomized Controlled Trial

  • Oluyemi A. ADERIBIGBE
    Correspondence
    Corresponding Author: Oluyemi A. Aderibigbe, MD, Department of Reproductive Biology, Division of Maternal-Fetal Medicine, Cleveland Clinic Lerner College of Medicine/Case Western Reserve University, 9500 Euclid Avenue, Cleveland OH Tel: 7153935081
    Affiliations
    Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, The MetroHealth System/Case Western Reserve University

    Department of Reproductive Biology, Division of Maternal-Fetal Medicine, University Hospitals Cleveland Medical Center/Case Western Reserve University

    Department of Reproductive Biology, Division of Maternal Fetal Medicine, Cleveland Clinic Lerner College of Medicine/Case Western Reserve University
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  • David N. HACKNEY
    Affiliations
    Department of Reproductive Biology, Division of Maternal-Fetal Medicine, University Hospitals Cleveland Medical Center/Case Western Reserve University
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  • Angela C. RANZINI
    Affiliations
    Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, The MetroHealth System/Case Western Reserve University
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  • Justin R. LAPPEN
    Affiliations
    Department of Reproductive Biology, Division of Maternal Fetal Medicine, Cleveland Clinic Lerner College of Medicine/Case Western Reserve University
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Published:November 16, 2022DOI:https://doi.org/10.1016/j.ajogmf.2022.100818

      ABSTRACT

      BACKGROUND

      : High quality evidence to inform the management of postpartum hypertension, including the optimal blood pressure (BP) threshold to initiate therapy, is lacking. Randomized trials have been conducted in pregnancy but there are no published trials to guide management in the postpartum period.

      OBJECTIVE

      : We conducted this randomized controlled trial to test our hypothesis that initiating antihypertensive therapy in the postpartum period at a threshold of 140/90 mmHg would result in less maternal morbidity than initiating therapy at a threshold of 150/95 mmHg.

      STUDY DESIGN

      : We performed a pragmatic multi-centered randomized controlled trial of patients aged 18-55 with postpartum hypertension. Patients with chronic hypertension, gestational hypertension, and preeclampsia without severe features were randomized to one of two BP thresholds to initiate treatment: persistent BP ≥ 150/95 mmHg (institutional standard or “liberal control” group) or ≥ 140/90 mmHg (intervention or “tight control” group). Our primary outcome was composite maternal morbidity defined as: severe hypertension (BP ≥ 160/110 mmHg) or preeclampsia with severe features, the need for a second antihypertensive agent, postpartum hospitalization > 4 days, and maternal adverse outcome secondary to hypertension as evidenced by pulmonary edema, acute kidney injury (creatinine level ≥ 1.1 mg/dl), cardiac dysfunction (e.g. elevated brain natriuretic peptide level) or cardiomyopathy, posterior reversible encephalopathy syndrome (PRES), cerebrovascular accident, or admission to an intensive care unit. Secondary outcomes included hospital readmission for hypertension, persistence of hypertension beyond 14 days, medication side effects, and time to BP control. We calculated that 256 women would provide 90% power to detect a relative 50% reduction in the primary outcome from 36% in the standard BP threshold group to 18% with a two-sided alpha set at 0.05 for significance. Data was analyzed using R statistical software.

      RESULTS

      : 256 patients were randomized including 128 to the “tight control” group (140/90 mmHg) and 128 to the “liberal control” group (150/95 mmHg). Patients in the “tight control” group had a higher BMI at delivery (37.1 ± 9.4 vs 34.9 ± 8.1 p= 0.04); otherwise, demographic and obstetric characteristics were similar between groups. The rate of the primary outcome was similar between groups (8.6 % vs 11.7%, p= 0.41; RR 0.73, 95% CI 0.35 to 1.53). The rates of all secondary outcomes and the individual components of the primary and secondary outcome measures were also similar between groups.

      CONCLUSION

      : In the postpartum period, initiation of antihypertensive therapy at a lower BP threshold of 140/90 mmHg did not decrease maternal morbidity or improve outcomes compared to a threshold 150/95 mmHg.

      Keywords

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