Key result
Oral maintenance antihypertensives match acute therapy for maternal outcomes in severe hypertension.
Why the study?
The SBP threshold of >= 160 mmHg used in pregnancy for acute anti-hypertensive treatment was initially adapted from expert opinion, whereas guidelines for non-pregnant adults support a threshold of >= 180 mmHg.
Does treating systolic blood pressures between 160-179 mmHg with oral maintenance antihypertensives and reserving acute antihypertensives for SBP ≥ 180 mmHg result in non-inferior rates of maternal adverse outcomes compared to treating persistent SBP ≥ 160 mmHg with acute antihypertensives in pregnant individuals ≥ 20 weeks?
RCT (n=1,002)
Before and after quality improvement non-inferiority design
No
Does treating systolic blood pressures between 160-179 mmHg with oral maintenance antihypertensives and reserving acute antihypertensives for SBP ≥ 180 mmHg result in non-inferior rates of maternal adverse outcomes compared to treating persistent SBP ≥ 160 mmHg with acute antihypertensives in pregnant individuals ≥ 20 weeks?
In pregnant individuals ≥ 20 weeks, treating SBP between 160-179 mmHg with oral maintenance antihypertensives while reserving acute treatment for SBP ≥ 180 mmHg was non-inferior for maternal adverse cardiovascular and renal outcomes and decreased acute antihypertensive use nearly 3-fold.
Objective: A systolic blood pressure (SBP) threshold 160 mmHg is used in pregnancy for acute anti-hypertensive treatment; however, this was initially adapted from expert opinion and guidelines for non-pregnant adults support a SBP 180 mmHg. We compared adverse maternal outcomes using a SBP threshold of 180 mmHg versus 160 mmHg for acute anti-hypertensive treatment, while treating SBPs between 160-179 mmHg (DBP 110 mmHg) with oral maintenance anti-hypertensives. Study Design: We performed a Quality Improvement before and after non-inferiority study (NCT05881252) of singletons 20 weeks’ with SBP 160 mmHg at a single Level 4 medical center. In the before group, acute antihypertensives (intravenous [IV] labetalol/hydralazine or rapid-acting oral nifedipine) were given for persistent SBP 160 mmHg (or DBP 110 mmHg). In the after group, oral maintenance antihypertensives (labetalol or extended-release nifedipine) were given if persistent SBP between 160-179 mmHg (DBP 110 mmHg) and acute antihypertensives for persistent SBP 180 mmHg (or DBP 110 mmHg). The primary outcome was a composite of congestive heart failure, pulmonary edema, cerebrovascular accident, acute kidney injury, or myocardial infarction. Bayesian analysis was performed using a non-inferiority margin of 4% and 1% (posthoc sensitivity analysis). Results: We studied 1,002 individuals (410 in before; 592 in after) with severe hypertension. The primary outcome occurred in 2.9% of the before and 1.9% of the after group (0.72 median relative risk, 95% credible interval 0.36-1.46) with an 82% probability of risk reduction in the after group and > 99.9% probability that the risk difference in the after group was < 4% (99% for a 1% margin). Use of acute antihypertensives per individual treated decreased almost 3-fold in the after group (mean 1.7 doses versus 0.6, p<0.01) Conclusion: In our population, treating SBPs between 160-180 mmHg with oral maintenance antihypertensives resulted in to a non-inferior rate of maternal adverse outcomes and decreased the use of
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Cagino et al. (2026) conducted an RCT in Severe systolic hypertension in pregnancy (n=1,002). Oral maintenance antihypertensives (labetalol or extended-release nifedipine) for SBP 160-179 mmHg and acute antihypertensives for SBP ≥ 180 mmHg vs. Acute antihypertensives (IV labetalol/hydralazine or rapid-acting oral nifedipine) for persistent SBP ≥ 160 mmHg (or DBP ≥ 110 mmHg) was evaluated on Composite of congestive heart failure, pulmonary edema, cerebrovascular accident, acute kidney injury, or myocardial infarction (RR 0.72, 95% CI 0.36-1.46, p=>99.9% probability of noninferiority (<4% margin)). Oral maintenance antihypertensives for SBP 160-179 mmHg were noninferior to acute therapy at ≥160 mmHg for adverse maternal outcomes (1.9% vs 2.9%; RR 0.72, 95% CrI 0.36-1.46).
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