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NCT07547046Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 23 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
350 (estimated)
First submitted
23 Mar 2026
Start date
1 Apr 2026
Primary completion date
7 May 2026
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT07547046

What you commit to

  • Study type: Observational
  • Planned participants: 350
  • From 1 Apr 2026 to the primary completion date, 7 May 2026
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Intravenous antihypertensive treatment initiated prior to inclusion

Other illness

  • Contraindication to labetalol (asthma, chronic obstructive pulmonary disease, bradycardia, current or history of intracardiac conduction disorders, or history of hypersensitivity reaction)

Other

  • Patient refusal or objection to the use of her healthcare data for research purposes

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Bordeaux
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BordeauxFranceUnknown status
Hopital Antoine Beclere
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ClamartFranceUnknown status
CHU Clermont-Ferrand
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Clermont-FerrandFranceUnknown status
Hopital Bicetre
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Le Kremlin-BicêtreFranceUnknown status
CHU Lille
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LilleFranceUnknown status
CHU Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant
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LyonFranceUnknown status
CHU Martinique
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MartiguesFranceUnknown status
CHRU Nancy
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NancyFranceUnknown status
CH Agen-Nerac
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NéracFranceUnknown status
CHU Carémeau
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NîmesFranceUnknown status
Hôpital Armand-Trousseau
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ParisFranceUnknown status
Hôpital Necker
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ParisFranceUnknown status
Hopital Cochin - Port Royal
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PARISFranceUnknown status
CH de Roubaix
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RoubaixFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.