Achieving Optimal Gestational Weight Gain, Birth Weight, and Perinatal Outcomes Among Pregnant Women at Risk of Hypertension: Protocol for a Pilot Randomized Controlled Trial

• Published in: JMIR research protocols 2020-06, Vol.9 (6), p.e16676-e16676
• Main Authors: Hasan, S M Tafsir, Ahmed, Syed Imran, Khan, Md Alfazal, Sarker, Shafiqul Alam, Ahmed, Tahmeed
• Format: Article
• Language: English
• Subjects: Algorithms; Artificial intelligence; Blood pressure; Body mass index; Clinical trials; Electrocardiography; Gestational age; Hypertension; Intervention; Machine learning; Maternal mortality; Original Paper; Physiology; Preeclampsia; Pregnancy; Premature birth; Prenatal care; Pressure measurement; Smartphones; Validation studies; Womens health
• ISSN: 1929-0748; 1929-0748
• DOI: 10.2196/16676

Background: Hypertensive 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. Objective: The 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. Methods: The 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. Results: A validation study of the wearable blood pressure device has successfully been conducted among the general adult population in M