Severe PreeclampsiaRELAPSENCT07547046
Factors Associated With Blood Pressure Control Failure to Intravenous Labetalol in Severe Preeclampsia
An observational study of Severe Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 14 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe Preeclampsia
- How many people
- 350 participants
- Where
- 14 sitesFrance
- Study dates
- 1 Apr 2026to 7 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult pregnant women with severe preeclampsia requiring intravenous labetalol as part of routine clinical care.
Who may be able to join
- 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 join
- Contraindication to labetalol (asthma, chronic obstructive pulmonary disease, bradycardia, current or history of intracardiac conduction disorders, or history of hypersensitivity reaction)
- Intravenous antihypertensive treatment initiated prior to inclusion
- Patient refusal or objection to the use of her healthcare data for research purposes
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites
CHU Bordeaux
Bordeaux
Aurélie SAN MIGUEL
Hôpital Antoine Béclère
Clamart
Agnès LE GOUEZ-DIVISIA, 1 45 37 42 73 ext. +33, agnes.le-gouez@aphp.fr
CHU Clermont-Ferrand
Clermont-Ferrand
Martine BONNIN, mbonnin@chu-clermontferrand.fr
Hôpital Bicêtre
Le Kremlin-Bicêtre
Marie BRUYERE, 1 45 21 34 41 ext. +33, marie.bruyere@aphp.fr
CHU Lille
Lille
Max GONZALEZ-ESTEVEZ, max.gonzalezestevez@chu-lille.fr
CHU Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant
Lyon
Lionel BOUVET
CHU Martinique
Martigues
Thibaut RACKELBOOM, thibaut.rackelboom@chu-martinique.fr
CHRU Nancy
Nancy
Florence VIAL, F.VIAL@chru-nancy.fr
CH Agen-Nerac
Nérac
Sandrine PAQUIN
CHU Carémeau
Nîmes
Estelle MORAU
Hôpital Armand-Trousseau
Paris
Marie-Pierre BONNET, 1 44 73 61 99 ext. +33, marie-pierre.bonnet@aphp.fr
Hôpital Cochin Port Royal
Paris
Catherine FISCHER, 1 58 41 41 41 ext. +33, catherine.fischer2@aphp.fr
Hôpital Necker
Paris
Hawa KEITA-MEYER, 1 44 49 41 72 ext. +33, hawa.keita@aphp.fr
CH de Roubaix
Roubaix
Anne-Sophie BAPTISTE, anne-sophie.baptiste@ch-roubaix.fr
About this study
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
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.
Read more
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.
Read the detailed description
Severe preeclampsia is a serious pregnancy complication associated with maternal and fetal morbidity and mortality, mainly due to insufficient blood pressure control. Intravenous labetalol is recommended as first-line treatment, but treatment failure is frequently observed in clinical practice, and its predictors are not well established.
The RELAPSE study is a prospective, multicenter observational study aiming to assess the association between predefined patient characteristics and failure of blood pressure control with intravenous labetalol monotherapy.
Data will be collected prospectively from routine clinical care and recorded in an electronic case report form. No additional procedures will be performed, and patient management will not be modified.
Approximately 350 patients will be included across multiple centers. Participants will be followed from initiation of intravenous labetalol until hospital discharge (up to a maximum of 7 days).
The primary analysis will evaluate the association between treatment failure and predefined factors using multivariable logistic regression. Results will be expressed as odds ratios with 95% confidence intervals.
This study aims to improve the identification of patients at risk of treatment failure and contribute to better management of severe preeclampsia.
- Conditions
- Severe Preeclampsia
- Keywords
- Severe preeclampsia, hypertensive disorders of pregnancy, pregnancy-related hypertension, maternal morbidity, antihypertensive treatment fa, intravenous labetalol; blood pressure control
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the first hour following initiation of intravenous labetalol administration
Secondary outcomes (5)
Adverse effects related to intravenous labetalol
Occurrence of adverse events potentially related to labetalol administration, including allergic reactions, bronchospasm, and neonatal hypoglycemia.
Measured: During the first hour following initiation of intravenous labetalol administration
Safety of intravenous labetalol administration
Occurrence of safety events defined as maternal hypotension (systolic blood pressure < 90 mmHg, diastolic blood pressure < 60 mmHg, or mean arterial pressure < 65 mmHg) and/or maternal bradycardia (heart rate < 50 beats per minute).
Measured: During the first hour following initiation of intravenous labetalol administration
Maternal and fetal morbidity and mortality
Occurrence of maternal and fetal complications related to severe preeclampsia or inadequate blood pressure control, including stroke, eclampsia, intracranial hemorrhage, placental abruption, intrauterine fetal death, posterior reversible encephalopathy syndrome, reversible cerebral vasoconstriction syndrome, pulmonary edema, maternal death, or neonatal death.
Measured: From initiation of intravenous labetalol treatment until hospital discharge (up to 7 days)
Predictive dose of intravenous labetalol failure
Total dose of intravenous labetalol administered prior to meeting criteria for treatment failure.
Measured: From initiation of intravenous labetalol treatment until treatment failure or blood pressure control, assessed during hospitalization (up to 7 days)
Emergency cesarean delivery
Occurrence of emergency cesarean section during hospitalization.
Measured: From initiation of intravenous labetalol treatment until hospital discharge (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion7 May 2026 (estimated)
- Study completion7 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547046
- Sponsor's protocol ID
- APHP251576
- Acronym
- RELAPSE
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07547046
- Acronym / sponsor ID
- RELAPSE / APHP251576
- Conditions
- Severe Preeclampsia
- Keywords
- Severe preeclampsia, hypertensive disorders of pregnancy, pregnancy-related hypertension, maternal morbidity, antihypertensive treatment fa, intravenous labetalol; blood pressure control
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 7 May 2026 (estimated)
- Study completion
- 7 May 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe preeclampsia is a serious pregnancy complication associated with maternal and fetal morbidity and mortality, mainly due to insufficient blood pressure control. Intravenous labetalol is recommended as first-line treatment, but treatment failure is frequently observed in clinical practice, and its predictors are not well established.
The RELAPSE study is a prospective, multicenter observational study aiming to assess the association between predefined patient characteristics and failure of blood pressure control with intravenous labetalol monotherapy.
Data will be collected prospectively from routine clinical care and recorded in an electronic case report form. No additional procedures will be performed, and patient management will not be modified.
Approximately 350 patients will be included across multiple centers. Participants will be followed from initiation of intravenous labetalol until hospital discharge (up to a maximum of 7 days).
The primary analysis will evaluate the association between treatment failure and predefined factors using multivariable logistic regression. Results will be expressed as odds ratios with 95% confidence intervals.
This study aims to improve the identification of patients at risk of treatment failure and contribute to better management of severe preeclampsia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult pregnant women with severe preeclampsia requiring intravenous labetalol as part of routine clinical care.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Contraindication to labetalol (asthma, chronic obstructive pulmonary disease, bradycardia, current or history of intracardiac conduction disorders, or history of hypersensitivity reaction)
- Intravenous antihypertensive treatment initiated prior to inclusion
- Patient refusal or objection to the use of her healthcare data for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure of blood pressure control with intravenous labetalol monotherapy
Time frame: During the first hour following initiation of intravenous labetalol administration
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).
5 secondary outcomes
Adverse effects related to intravenous labetalol
Time frame: During the first hour following initiation of intravenous labetalol administration
Safety of intravenous labetalol administration
Time frame: During the first hour following initiation of intravenous labetalol administration
Maternal and fetal morbidity and mortality
Time frame: From initiation of intravenous labetalol treatment until hospital discharge (up to 7 days)
Predictive dose of intravenous labetalol failure
Time frame: From initiation of intravenous labetalol treatment until treatment failure or blood pressure control, assessed during hospitalization (up to 7 days)
Emergency cesarean delivery
Time frame: From initiation of intravenous labetalol treatment until hospital discharge (up to 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnès LE GOUEZ-DIVISIA (1 45 37 42 73 ext. +33, agnes.le-gouez@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of blood pressure control with intravenous labetalol monotherapy (time frame: During the first hour following initiation of intravenous labetalol administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.