CHIPS

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Magee LA, et al. "Less-tight versus tight control of hypertension in pregnancy". The New England Journal of Medicine. 2015. 372(5):407-417.
PubMed

Clinical Question

The effect of tight vs less-tight hypertension control in pregnant patients.

Bottom Line

There was no significant difference between hypertension control groups in risk of pregnancy loss, high level neonatal care or increased maternal complications. There was an increased incidence of severe maternal hypertension in the less-tight blood pressure control group. This study also showed a tighter blood pressure control was not associated with worse perinatal outcomes such as small gestational age.

Major Points

Guidelines

No guidelines have adopted the results of this study as of November 2015.

Design

  • Open, multicenter, international, randomized, controlled trial
  • N=1030
    • Less-tight control (n=519)
    • Tight control (n=511m)
  • Setting: 94 sites, international
  • Enrollment: March 26, 2009, to August 2, 2012
  • Mean follow-up:
  • Analysis: intention-to-treat
  • Primary outcome: pregnancy loss or high-level neonatal care for more than 48 hours during the first 28 postnatal days Please do not list secondary or other outcomes.

Population

Inclusion Criteria

  • Pre-existing or gestational hypertension
  • dBP 90-105 mmHg if not taking antihypertensives, and dBP 85-105 if taking antihypertensives
  • live fetus
  • gestational age 14-33+6 weeks

Exclusion Criteria

  • Severe systolic hypertension, sBP >160 at randomization
  • Proteinuria, defined >0.3/d by 24hr urine collection, or protein:creatinine ratio >30mg/mmol
  • Use of an ACE inhibitor at any time in pregnnacy
  • Contraindication to either arm or to pregnancy prolongation. Woman within one week of anticipated delivery
  • Known multiple gestation
  • Known lethal or major fetal anomaly
  • Planned termination
  • Prior participation

Baseline Characteristics

  • Less-tight Control
  • Maternal Age 34
  • BMI >30 49.7%
  • Cigarette Smoking 7%
  • Nulliparous 32.4%
  • Weeks of gestation age 23.7
  • Type of nonproteinuric hypertension
    • pre-existing 74.6%
    • gestational 25.4%
  • Antihypertensive medication at enrollment 56.1%
  • Blood pressure within 1 week before randomization 140.4/92.6
  • Currently monitoring blood pressure at home 37.2%
  • Gestational diabetes at enrollment 6.4%

Interventions

Outcomes

Primary Outcome

Secondary Outcomes

Subgroup Analysis

Adverse Events

Criticisms

Funding

Further Reading