Feasibility of multi-component intervention for blood pressure control in pregnancy in Nigeria and Ghana: a pilot randomized clinical trial

Abstract

BACKGROUND: Hypertensive disorders in pregnancy are a leading cause of maternal and fetal morbidities and mortalities. They are 5 times as prevalent in Sub-Saharan Africa with relatively higher rate of adverse outcomes. Challenges in management are as a result of physiologic changes in pregnancy, restricted choice of antihypertensives, sub-optimal response to medications in pregnancy and the exclusion of pregnant women from most drug trials. Objectives of this study are to determine the feasibility of delivering multi-component intervention for blood pressure control in women with chronic hypertension in pregnancy, evaluate mean change in systolic blood pressure over the follow-up period, proportion of participants who achieve optimal blood pressure control and the occurrence of adverse maternal and fetal outcomes. METHODOLOGY: This was a pilot multi-center randomized controlled trial involving 60 pregnant women with chronic hypertension in pregnancy randomized into intervention arm (multi-components intervention) and control arm (usual care) in 2 tertiary hospitals in Nigeria and Ghana. Key outcomes were feasibility indices, mean change in blood pressure, proportion of subjects that achieved normal blood pressure, and adverse maternal/fetal outcomes. Data was analysed using Statistical Package for Social Sciences Software (SPSS version 23, 2011, SPSS Inc. Chicago, Illinois). Key feasibility indices were determined, mean difference of blood pressures across all study visits calculated and pairwise comparisons made using Bonferroni correction. Comparison of proportion with uncontrolled BP were made in both study groups. Proportions of Maternal/perinatal outcomes were identified. RESULTS: Retention rates were 86.7% and 96.7% in Nigeria and Ghana respectively. Mean change in systolic and diastolic blood pressures in the intervention arm from study enrolment to completion was 10.6mmHg (3.1 - 18.1) (p=0.007) and 6.9mmHg (1.9 - 11.9) (p=0.009) respectively. Proportion of participants who achieved optimal blood pressure were comparable between the two groups (20% in the intervention group and 24.1% in the control, p =0.701). Occurrence of adverse maternal/fetal outcomes were comparable in both groups, however, the odds of developing superimposed pre-eclampsia was 27% more in the control group compared to intervention group. CONCLUSION: It is feasible and acceptable to deliver multi-component intervention for blood pressure control in pregnant women with chronic hypertension in Africa.