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
- Diseases
- High blood pressure
- 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
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hopital Antoine Beclere Coordinator of this site? Confirm its status | Clamart | France | Unknown status |
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Hopital Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| CHU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHU Martinique Coordinator of this site? Confirm its status | Martigues | France | Unknown status |
| CHRU Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| CH Agen-Nerac Coordinator of this site? Confirm its status | Nérac | France | Unknown status |
| CHU Carémeau Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Hôpital Armand-Trousseau Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Necker Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Cochin - Port Royal Coordinator of this site? Confirm its status | PARIS | France | Unknown status |
| CH de Roubaix Coordinator of this site? Confirm its status | Roubaix | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.