Effect of Multi-component Intervention for Blood Pressure control in Pregnancy: A pilot study - Trial PACTR202306896247858

Timeline & Enrollment

Summary

Hypertensive disorders in pregnancy affect approximately 18 million pregnancies worldwide annually and are a leading cause of maternal and fetal morbidity and mortality. Globally, an estimated 42,000 individuals annually die from complications of hypertension in pregnancy, accounting for about 14% of total maternal deaths. Additionally, approximately 15% of the 2.6 million stillbirths that occur worldwide each year are attributed to hypertensive disorders of pregnancy.Studies have shown that the addition of non-pharmacological measures are effective in improving medication adherence, achieving sustained blood pressure control, and reducing complications in patients with chronic medical disorders. However, pregnant women are mostly excluded from such clinical trials, hence, its impact on feto-maternal outcomes in the pregnant population has not been widely studied.This is a pilot study to be conducted in two African countries (Nigeria and Ghana), which seeks to assess the feasibility and effect of a multi-component approach to blood pressure control compared to pharmacologic treatment alone on feto-maternal outcomes in pregnant women with chronic hypertension. The multi-component approach includes standard pharmacologic treatment for blood pressure control, home blood pressure monitoring, regular extensive counseling on lifestyle modifications and medication adherence, and regular SMS messages to reinforce counseling.The Primary objectives are to determine the feasibility of conducting a multi-component intervention study among pregnant women with chronic hypertension by assessing the participant recruitment rates, retention rates, fidelity to the protocol,and acceptability, while the secondary objective are to determine the mean change in systolic blood pressure, proportion of participants who achieve optimal blood pressure control, and the occurrence of adverse perinatal outcomes in the participants.

ICD-10 Classifications