Severe preeclampsia is a serious pregnancy complication associated with maternal and fetal morbidity and mortality, mainly due to insufficient blood pressure control. Intravenous labetalol is recommended as first-line treatment, but treatment failure is frequently observed in clinical practice, and its predictors are not well established.
The RELAPSE study is a prospective, multicenter observational study aiming to assess the association between predefined patient characteristics and failure of blood pressure control with intravenous labetalol monotherapy.
Data will be collected prospectively from routine clinical care and recorded in an electronic case report form. No additional procedures will be performed, and patient management will not be modified.
Approximately 350 patients will be included across multiple centers. Participants will be followed from initiation of intravenous labetalol until hospital discharge (up to a maximum of 7 days).
The primary analysis will evaluate the association between treatment failure and predefined factors using multivariable logistic regression. Results will be expressed as odds ratios with 95% confidence intervals.
This study aims to improve the identification of patients at risk of treatment failure and contribute to better management of severe preeclampsia.
