Optimizing Gestational Weight Gain, Birth Weight and Perinatal Outcomes among Pregnant Women at Risk of Hypertension in Pregnancy by Regular Monitoring of Weight Gain and Blood Pressure: Study Protocol for a Pilot Randomized Controlled Trial (Preprint) release_pceax4adybc2pb6j73r7fr3kwe

Abstract

Hypertensive disorders of pregnancy (HDP), 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 causes. Conventional antenatal care (ANC) practices often delay in detecting or miss HDP, which makes the women vulnerable to their adverse consequences. Regular self-monitoring of blood pressure (BP) and weight gain may optimize maternal and fetal outcomes among pregnant women at risk of developing HDP through early diagnosis, prompt referral, and timely clinical management. To undertake a randomized controlled trial (RCT) of this intervention to reduce adverse consequences of HDP raises concerns about its feasibility. The objectives of this study are to evaluate the accuracy of a wearable BP measuring device (Health Gauge [HG]), to test the design and methods of a future definitive RCT, and to examine the feasibility, acceptability and fidelity of an intervention focusing on regular monitoring of weight gain during pregnancy and self-monitoring of BP among pregnant women at risk of developing HDP or their complications. The study will be conducted in two phases in Matlab, Bangladesh: 1) validation of HG according to the European Society of Hypertension International Protocol revision 2010, and 2) a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. In the pilot trial, 70 eligible participants will be individually randomized 1:1 to the intervention arm in which pregnant women will self-monitor their BP daily using a wearable device (HG) and be evaluated for weight gain monthly 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. All women will receive standard ANC. A validation study among the general adult population in Matlab has been conducted successfully. The pilot trial has completed enrollment. The follow-up of the participants is ongoing, and results are forthcoming. The findings of this study will help us design a comprehensive, full-scale RCT to test the efficacy of a simple and inexpensive intervention such as regular self-monitoring of BP and weight gain during pregnancy aimed at optimizing maternal and fetal outcomes among pregnant women at risk of developing HDP or their complications. ClinicalTrials.gov NCT03858595; https://clinicaltrials.gov/ct2/show/NCT03858595.
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