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

NCT07547046 | Not Yet Recruiting

• 1 other identifier: APHP251576
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Severe Preeclampsia

Keywords

Severe preeclampsia; hypertensive disorders of pregnancy; pregnancy-related hypertension; maternal morbidity; antihypertensive treatment fa; intravenous labetalol; blood pressure control

Outcome Measures

Primary Outcomes (1)

• 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).

  During the first hour following initiation of intravenous labetalol administration

Secondary Outcomes (5)

• Adverse effects related to intravenous labetalol

  During the first hour following initiation of intravenous labetalol administration

• Safety of intravenous labetalol administration

  During the first hour following initiation of intravenous labetalol administration

• Maternal and fetal morbidity and mortality

  From initiation of intravenous labetalol treatment until hospital discharge (up to 7 days)

• Predictive dose of intravenous labetalol failure

  From initiation of intravenous labetalol treatment until treatment failure or blood pressure control, assessed during hospitalization (up to 7 days)

• Emergency cesarean delivery

  From initiation of intravenous labetalol treatment until hospital discharge (up to 7 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult pregnant women with severe preeclampsia requiring intravenous labetalol as part of routine clinical care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (14)

CHU Bordeaux

Bordeaux, France

Location

Hôpital Antoine Béclère

Clamart, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

CHU Lille

Lille, France

Location

CHU Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant

Lyon, France

Location

CHU Martinique

Martigues, France

Location

CHRU Nancy

Nancy, France

Location

CH Agen-Nerac

Nérac, France

Location

CHU Carémeau

Nîmes, France

Location

Hôpital Armand-Trousseau

Paris, France

Location

Hôpital Cochin Port Royal

Paris, France

Location

Hôpital Necker

Paris, France

Location

CH de Roubaix

Roubaix, France

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Agnès LE GOUEZ-DIVISIA

CONTACT

1 45 37 42 73; agnes.le-gouez@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-03

Locations

FR (14)