Looking for reasons labetalol fails to lower blood pressure in severe preeclampsia
Looks at why intravenous labetalol sometimes fails to control blood pressure in severe preeclampsia.
Plain-language title generated from the registry record
Registry title: Factors Associated With Blood Pressure Control Failure to Intravenous Labetalol in Severe Preeclampsia
Key facts
- Where
- Bordeaux, Clamart, Clermont-Ferrand, Le Kremlin-Bicêtre, Lille, Lyon, Martigues, Nancy, Nérac, Nîmes, Paris, PARIS, and Roubaix, FranceSee the 14 sites
Where in France
- CHU BordeauxBordeaux, FranceNo longer taking part
- Hopital Antoine BeclereClamart, FranceNo longer taking part
- CHU Clermont-FerrandClermont-Ferrand, FranceNo longer taking part
- Hopital BicetreLe Kremlin-Bicêtre, FranceNo longer taking part
- CHU LilleLille, FranceNo longer taking part
- CHU Hospices Civils de Lyon, Hôpital Femme-Mère-EnfantLyon, FranceNo longer taking part
- CHU MartiniqueMartigues, FranceNo longer taking part
- CHRU NancyNancy, FranceNo longer taking part
- CH Agen-NeracNérac, FranceNo longer taking part
- CHU CarémeauNîmes, FranceNo longer taking part
- Hôpital Armand-TrousseauParis, FranceNo longer taking part
- Hôpital NeckerParis, FranceNo longer taking part
- Hopital Cochin - Port RoyalPARIS, FranceNo longer taking part
- CH de RoubaixRoubaix, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT07547046
- Record updated
- 23 April 2026
- Original description
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.Read full original descriptionShow less
Assessment of the Association Between Predefined Factors and Response or Failure of Blood Pressure Control With Intravenous Labetalol Monotherapy in Severe Preeclampsia: a Multicenter Observational Study
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.
Inclusion: 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.
Exclusion: Intravenous antihypertensive treatment initiated prior to inclusion; Contraindication to labetalol (asthma, chronic obstructive pulmonary disease, bradycardia, current or history of intracardiac conduction disorders, or history of hypersensitivity reaction); Patient refusal or objection to the use of her healthcare data for research purposes.