Remote Patient Monitoring for Chronic Hypertension During Pregnancy (REACH)

Hypotheses / Research Question(s) Specific Aim 1: To evaluate whether remote patient blood pressure monitoring during the antepartum period for patients with chronic hypertension will improve composite perinatal outcomes. Hypothesis: In patients with chronic hypertension, tight blood pressure control with remote patient monitoring will improve composite outcomes. Participants in the two trial arms will be compared for the frequency of composite perinatal outcomes (perinatal death, placental abruption, superimposed preeclampsia with severe features, or indicated preterm birth <35 weeks). Compliance with the assigned study group will also be assessed.

Specific Aim 2: Assess the impact of remote patient monitoring for chronic hypertension during pregnancy on changes in cardiac strain. Hypothesis: Tight blood pressure control using remote patient monitoring will decrease maladaptive cardiac remodeling during late gestation, which will persist into the postpartum period. Cardiac strain will be assessed using speckle-tracking echocardiography at enrollment and 34 to 36 weeks of gestation.

Exploratory Aim: To compare the accuracy of OB/GYN-derived Point of Care Ultrasound (POCUS) cardiac strain assessments and diastolic parameters to the echocardiogram-derived assessment, we will seek to determine if POCUS images obtained by a physician without echocardiogram training will produce reliable results compared to those obtained with an echocardiogram.

Research Significance Chronic hypertension is defined as preexisting hypertension (>=140/90 mmHg) diagnosed before 20 weeks' gestation.1 In the United States, 2-6% of all pregnancies are complicated by chronic hypertension, resulting in up to 260,000 births to women with chronic hypertension each year.1-3 There is an increasing number of patients with chronic hypertension during pregnancy,4 and chronic hypertension disproportionally impacts Black pregnant women compared to their White counterparts.5 Of those with chronic hypertension, 25-30% will develop superimposed preeclampsia with severe features.1 Additional adverse outcomes for chronic hypertension in pregnancy are substantial and include small for gestational age birth, abruption, preterm birth, and perinatal death.1,6 Chronic hypertension in pregnancy is associated with an increased risk of superimposed preeclampsia (incidence 25-30%, relative risk compared to no chronic hypertension 3-4),2,7-10 placental abruption (incidence 1.5%, relative risk 2-3),1,2,10 preterm birth before 35 weeks (incidence 18-22%, relative risk 3-4),1,3,7,9,11 and perinatal death (incidence 6-8%, relative risk 3-5).1,2,10 Recently, Tita et al.6 published the Chronic Hypertension and Pregnancy (CHAP) randomized trial of 2,408 pregnant patients with chronic hypertension. This trial showed a 21% decrease in preeclampsia by targeting a blood pressure goal of less than 140/90 mmHg. This study was conducted using in-office blood pressure measurements to titrate medication.6 Whether using home blood pressure readings to optimize treatment further improves clinical outcomes is unknown. Of the patients in the active treatment arm (n=1170), 30.2% had one of the composite primary outcomes compared to 37.0% in the control arm (n=1155). More specifically, preeclampsia with severe features occurred in 23.3%, medically indicated preterm birth before 35 weeks occurred in 12.2%, placental abruption occurred in 1.7%, and fetal or neonatal death before 28 days of life occurred in 3.5%.6 Despite the clinically meaningful reduction in the primary outcome of the CHAP trial, it is unknown if remote patient monitoring can further decrease these adverse maternal and neonatal outcomes.

With the growth of remote clinical monitoring, many patients with chronic hypertension take their blood pressure outside of a medical setting. The United States Preventive Services Task Force recommends confirmation of hypertension outside of pregnancy based on out-of-office blood pressure measurements.1 The decision to treat hypertension based on out-of-office blood pressure measurements is complicated by the fact that studies have shown that non-pregnant patients have home blood pressure measurements that are 5-15 mmHg lower than in-office readings.13 Nevertheless, studies in nonpregnant patients have shown improved blood pressure control with 12 months of remote patient monitoring versus standard treatment alone (72% versus 57%).14 If treating in-office blood pressure readings alone, it may lead to overtreatment in some patients and missed opportunities for medication titration in others.