Factors Associated With Blood Pressure Control Failure to Intravenous Labetalol in Severe Preeclampsia

Severe preeclampsia is a serious pregnancy complication that can lead to severe maternal and fetal outcomes, particularly when blood pressure is not adequately controlled. In France, intravenous labetalol is recommended as the first-line treatment for severe hypertension in preeclampsia. However, in clinical practice, failure to control blood pressure with labetalol is frequently observed, and the factors associated with this lack of response remain poorly understood. The RELAPSE study is a prospective, multicenter observational study designed to identify factors associated with failure of blood pressure control with intravenous labetalol monotherapy in patients with severe preeclampsia. The main hypothesis is that certain patient characteristics, such as maternal clinical profile, obstetric history, or biological parameters, may be associated with a higher risk of treatment failure. Identifying these factors could help clinicians better anticipate inadequate response to labetalol and adapt treatment strategies more rapidly. Data will be collected from routine clinical care without modifying patient management. Patients will be followed from the initiation of intravenous labetalol until hospital discharge. The study will include approximately 350 patients across multiple centers. By improving the understanding of predictors of treatment failure, this study aims to contribute to better management of severe preeclampsia and to reduce maternal and neonatal complications.

NCT Number	NCT07547046
Lead Sponsor	Assistance Publique - Hôpitaux de Paris
Conditions	Severe Preeclampsia
Enrollment	350 participants
Start Date	2026-04-01
Primary Completion	2026-05-07 (estimated)
Study Completion	2026-05-07 (estimated)
Updated on ClinicalTrials.gov	2026-04-23