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.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Bordeaux, Clamart, Clermont-Ferrand, Le Kremlin-Bicêtre, Lille, Lyon, Martigues, Nancy, Nérac, Nîmes, Paris, PARIS, and Roubaix, FranceSee the 14 sites
- Trial code
- Registry title
- Factors Associated With Blood Pressure Control Failure to Intravenous Labetalol in Severe Preeclampsia
- Status
- Not yet recruiting
- People taking part
- 350 people, planned
- Started
- 1 Apr 2026
- Planned end
- 7 May 2026
- Type of study
- Observational
- Record updated
- 23 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant women aged 18 or older with severe preeclampsia who need intravenous labetalol to lower their blood pressure.
- Age
- 18 years or older
- Sex
- Women
- Disease stage
- Severe preeclampsia, pregnancy of 24 weeks or more with one or more viable fetuses, needing intravenous labetalol (continuous infusion or bolus titration)
- Earlier treatment
- No intravenous blood pressure treatment started before joining the study
Main reasons for not taking part
- Cannot take labetalol (asthma, chronic obstructive pulmonary disease, slow heartbeat, heart conduction problems, or past allergic reaction)
- Already received intravenous blood pressure treatment before joining
- Refuses the use of her health data for research
This trial only enrols pregnant participants. The registry sentence this rests on: 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
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
- CHU BordeauxBordeaux, FranceContact: Aurélie SAN MIGUELNo longer taking part
- Hopital Antoine BeclereClamart, FranceContact: Agnès LE GOUEZ-DIVISIANo longer taking part
- CHU Clermont-FerrandClermont-Ferrand, FranceContact: Martine BONNINNo longer taking part
- Hopital BicetreLe Kremlin-Bicêtre, FranceContact: Marie BRUYERENo longer taking part
- CHU LilleLille, FranceContact: Max GONZALEZ-ESTEVEZNo longer taking part
- CHU Hospices Civils de Lyon, Hôpital Femme-Mère-EnfantLyon, FranceContact: Lionel BOUVETNo longer taking part
- CHU MartiniqueMartigues, FranceContact: Thibaut RACKELBOOMNo longer taking part
- CHRU NancyNancy, FranceContact: Florence VIALNo longer taking part
- CH Agen-NeracNérac, FranceContact: Sandrine PAQUINNo longer taking part
- CHU CarémeauNîmes, FranceContact: Estelle MORAUNo longer taking part
- Hôpital Armand-TrousseauParis, FranceContact: Marie-Pierre BONNETNo longer taking part
- Hôpital NeckerParis, FranceContact: Hawa KEITA-MEYERNo longer taking part
- Hopital Cochin - Port RoyalPARIS, FranceContact: Catherine FISCHERNo longer taking part
- CH de RoubaixRoubaix, FranceContact: Anne-Sophie BAPTISTENo longer taking part
About the trial
What the trial wants to find out
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
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.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Looking for reasons labetalol fails to lower blood pressure in severe preeclampsiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 23 April 2026