Abstract
BackgroundHypertensive disorders, including preeclampsia, complicate 10% of all pregnancies, causing maternal and fetal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive disorders. Conventional antenatal care practices often delay or miss detecting hypertensive disorders in pregnancy, which may allow some women to become vulnerable to the adverse consequences of the hypertensive disorders. Regular self-monitoring of blood pressure and weight gain may improve maternal and fetal outcomes among pregnant women at risk of developing hypertensive disorders during pregnancy through early diagnosis, prompt referral, and timely clinical management; however, to undertake a randomized controlled trial of an intervention to reduce adverse consequences of hypertensive disorders in pregnancy, its feasibility must first be determined.ObjectiveThe objectives of this study are to evaluate the accuracy of a wearable blood pressure monitoring device (Health Gauge) in order to test the design and methods of a future definitive randomized controlled trial, and to examine the feasibility, acceptability, and fidelity of an intervention focusing on regular monitoring of weight gain and self-monitoring of blood pressure for pregnant women at risk of developing hypertensive disorders and their associated complications.MethodsThe study is located in Matlab, Bangladesh will be conducted in two phases. First, a wearable blood pressure device (Health Gauge) will be validated in accordance with the European Society of Hypertension International Protocol (revision 2010). Second, a prospective, two-arm, parallel, and nonblinded randomized controlled external pilot trial will be conducted. In the pilot trial, 70 eligible participants will be individually randomized to the intervention arm, in which pregnant women will self-monitor their blood pressure daily using a wearable device (Health Gauge) and be evaluated monthly by trained health workers for weight gain from 20 weeks of gestation until delivery, or the control arm, in which pregnant women will be assessed for weight gain every two months from 20 weeks of gestation until delivery (1:1 intervention to control allocation ratio using a permuted block randomization method with concealment). All women will receive standard antenatal care.ResultsA validation study of the wearable blood pressure device has successfully been conducted among the general adult population in Matlab, Bangladesh. As of September 2019, the pilot trial has completed enrollment of women who are pregnant (N=70; intervention: n=35; control: n=35) and follow-up of the participants is ongoing. Data analysis is expected to be completed by June 2020, and results are expected to be submitted for publication in August 2020.ConclusionsThe findings of this study will help us to design a comprehensive, full-scale randomized controlled trial to test the efficacy of regular self-monitoring of blood pressure and weight gain during pregnancy, a simple and inexpensive intervention to help to achieve optimal maternal and fetal outcomes in pregnant women at risk of developing hypertensive disorders and their associated complications during pregnancy.Trial RegistrationClinicalTrials.gov NCT03858595; https://clinicaltrials.gov/ct2/show/NCT03858595International Registered Report Identifier (IRRID)DERR1-10.2196/16676
Highlights
BackgroundHypertensive disorders complicate 10% of all pregnancies worldwide [1]
70 eligible participants will be individually randomized to the intervention arm, in which pregnant women will self-monitor their blood pressure daily using a wearable device (Health Gauge) and be evaluated monthly by trained health workers for weight gain from 20 weeks of gestation until delivery, or the control arm, in which pregnant women will be assessed for weight gain every two months from 20 weeks of gestation until delivery (1:1 intervention to control allocation ratio using a permuted block randomization method with concealment)
Data analysis is expected to be completed by June 2020, and results are expected to be submitted for publication in August 2020
Summary
BackgroundHypertensive disorders complicate 10% of all pregnancies worldwide [1]. They include chronic hypertension (pre-existing or when detected prior to 20 weeks of gestation), white-coat hypertension (an elevated blood pressure at clinic but normal blood pressure at home), masked hypertension (normal blood pressure at clinic but elevated blood pressure at home), gestational hypertension (elevated blood pressure detected after 20 weeks but no other systemic manifestations), and preeclampsia (elevated blood pressure detected after 20 weeks with proteinuria or biochemical or hematological abnormalities) [2]. Hypertensive disorders during pregnancy lead to fetal growth restriction, preterm birth, and increased perinatal mortality [3]. Small for gestational age births, and malnutrition in children under five years age in Bangladesh and other low- and middle-income countries are the major concerns of many governments and international agencies [8]; the most tractable pathways for effective interventions to promote healthy pregnancy, gestational weight gain, and fetal growth remain uncertain. Regular self-monitoring of blood pressure and weight gain may improve maternal and fetal outcomes among pregnant women at risk of developing hypertensive disorders during pregnancy through early diagnosis, prompt referral, and timely clinical management; to undertake a randomized controlled trial of an intervention to reduce adverse consequences of hypertensive disorders in pregnancy, its feasibility must first be determined
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