Hypertensive Disorders of Pregnancy Form
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Background for this Policy
Obstetrical hypertension programs offer a "package" approach to the outpatient care of the hypertensive pregnant patient. These programs typically use a device to measure blood pressure and pulse, and to transmit measurements of daily weight, fetal movement count, and urine proteinuria. The programs do not assure patient compliance with physician instructions regarding the ambulatory management hypertension.
For mild preeclampsia, conservative management is recommended by the American College of Obstetricians and Gynecologists (ACOG) for any woman not undergoing delivery. Conservative management involves monitoring the patient's blood pressure, proteinuria, renal and hepatic function, platelet counts, and serial sonography for fetal growth. The frequency with which these parameters are monitored should depend on gestational age and circumstance of the patient and fetus. Inpatient or outpatient management may be appropriate.
An ACOG Practice Bulletin on hypertension in pregnancy (ACOG, 2019) recommends that pregnant women with hypertension be instructed on measuring blood pressure monitoring at home. "Although out-of-office and self-monitoring of blood pressure has not been evaluated in pregnant women with hypertension, the literature examining nonpregnant women with hypertension suggest that it is safe to use in both populations. Presumed advantages of out-of-office and self-monitoring include patient convenience, increased therapeutic adherence, confirmation of white coat hypertension, and assistance with adjusting medications when there is uncertainty. . . Procedures for the use of home blood pressure monitoring are available and emphasize patient training, use of appropriately validated devices, and clear instructions. . . . . Home monitoring may reduce the frequency of office visits in cases with marginal blood pressure control."
Lanssens, et al. (2017) reported on a single-center retrospective cohort "pilot study" to evaluate the added value of a remote follow-up program for pregnant women diagnosed with gestational hypertension. The authors noted that this was the first study of the added value of remote monitoring for women with gestational hypertension. The study was performed in the outpatient clinic of a 2nd level prenatal center in Belgium where pregnant women with gestational hypertention received remote monitoring or conventional care. Women consenting for remote monitoring received obstetric surveillance by a wireless blood pressure monitor, a smart body analyzer, and a pulse oximeter. Pregnant women participating in the prenatal remote follow-up program were asked to perform one blood pressure measurement in the morning and one in the evening, one weight measurement a day, and wear an activity tracker day and night until delivery or hospital admission. The data from the monitor devices were transmitted to a Web-based dashboard. Predetermined alarm signals were set; one midwife performed remote follow-up of all transformed data at the dashboard. She had to discriminate normal and alarm signals of systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg, or weight gain >1 kg/day. Alarm events were communicated with the obstetrician in charge to discuss management options before contacting and instructing patients at home. Type of interventions were:
Therapeutic interventions were according to local management. Primary study endpoints include number of prenatal visits and admissions to the prenatal observation ward. Secondary outcomes include gestational outcome, mode of delivery, neonatal outcome, and admission to neonatal intensive care (NIC). Of the 166 patients diagnosed with gestational hypertension, 53 received remote monitoring and 113 conventional care. After excluding 5 patients in the remote monitoring group and 15 in the conventional care group because of the missing data, 48 patients in remote monitoring group and 98 in conventional care group were taken into final analysis. The remote monitoring group had more women diagnosed with gestational hypertension, but less with preeclampsia when compared with conventional care (81.25% vs 42.86% and 14.58% vs 43.87%). Compared with conventional care, univariate analysis in remote monitoring showed less induction, more spontaneous labors, and less maternal and neonatal hospitalizations (48.98% vs 25.00%; 31.63% vs 60.42%; 74.49% vs 56.25%; and 27.55% vs 10.42%). This was also true in multivariate analysis, except for hospitalizations. The authors concluded that a remove monitoring follow-up of women with gestational hypertension is a promising tool in prenatal care.
A systematic evidence review of telehealth interventions in obstetrics and gynecology (DeNicola, et al., 2020), commenting on this study, noted that, "although there was a reasonable consistent trend toward the outcomes observed, outcomes were imprecise, with small sample size and two different clinical parameters (GDM and gestational hypertension)." The review also stated that there was a trend toward a high risk of selection bias in this study, also noting that there was an imbalance in number of participants assigned to each group. The review observed that this study reported no difference in clinical outcomes, without reporting data to support this conclusion. The review also stated that the applicability of this study to the U.S. health care system must be viewed with caution, given that this study was performed outside of the United States.
A randomized controlled trial of remote monitoring for gestational hypertension is currently underway (Lanssens, et al., 2020).
PEPredictDx
PEPredictDx is a test designed to measure patient’s serum of 3 protein biomarkers (kinase insert domain receptor [KDR], endoglin [ENG], and retinol binding protein 4 [RBP4]) for pre-eclampsia (PE); its algorithm reported as a PE risk score to identify high-risk PE patients. However, there is a lack of evidence regarding the effectiveness of this test.
Scope of Policy
This Clinical Policy Bulletin addresses hypertensive disorders of pregnancy.
Experimental and Investigational
The following interventions are considered experimental and investigational because the effectiveness of these approaches has not been established:
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