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.
Adult patient (age ≥ 18 years)
Pregnancy ≥ 24 weeks of gestation with one or more viable fetuses and severe preeclampsia requiring intravenous labetalol administration, either as continuous infusion (IVSE) or intravenous bolus titration
Contraindication to labetalol (asthma, chronic obstructive pulmonary disease, bradycardia, current or history of intracardiac conduction disorders, or history of hypersensitivity reaction)
Intravenous antihypertensive treatment initiated prior to inclusion
Patient refusal or objection to the use of her healthcare data for research purposes
Adult pregnant women with severe preeclampsia requiring intravenous labetalol as part of routine clinical care.
Cohort
Prospective
Not listed
Failure of blood pressure control with intravenous labetalol monotherapy
Composite outcome defined as failure to achieve blood pressure control with intravenous labetalol monotherapy in patients with severe preeclampsia. Failure is defined by the occurrence of at least one of the following: addition or switch to another antihypertensive treatment; persistence of severe hypertension after four intravenous labetalol boluses; persistence of hypertension despite continuous intravenous labetalol infusion at the maximum dose of 1 mg/kg/h; or occurrence of a complication attributable to inadequate blood pressure control (e.g., stroke, eclampsia, pulmonary edema, maternal or neonatal death).
Adverse effects related to intravenous labetalol
Occurrence of adverse events potentially related to labetalol administration, including allergic reactions, bronchospasm, and neonatal hypoglycemia.
Safety of intravenous labetalol administration
Occurrence of safety events defined as maternal hypotension (systolic blood pressure \< 90 mmHg, diastolic blood pressure \< 60 mmHg, or mean arterial pressure \< 65 mmHg) and/or maternal bradycardia (heart rate \< 50 beats per minute).
Maternal and fetal morbidity and mortality
Occurrence of maternal and fetal complications related to severe preeclampsia or inadequate blood pressure control, including stroke, eclampsia, intracranial hemorrhage, placental abruption, intrauterine fetal death, posterior reversible encephalopathy syndrome, reversible cerebral vasoconstriction syndrome, pulmonary edema, maternal death, or neonatal death.
Predictive dose of intravenous labetalol failure
Total dose of intravenous labetalol administered prior to meeting criteria for treatment failure.
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