Pre-eclampsiaHOPENCT06588023
Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients (HOPE)
An observational study of Pre-eclampsia and Pre-Eclampsia, Severe, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Preeclampsia (PE) is an obstetric placental vascular pathology with a prevalence of 2 to 5% of pregnant women. It is defined by learned societies by the association of high blood pressure (BP≥140/90mmHg) and proteinuria \> 0.3g/day. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-eclampsia, Pre-Eclampsia, Severe
- What is being tested?
- Observational study to evaluate professional practices
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2024to Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Pre-eclamptic patients undergoing cesarean section in the maternity wards of the Clermont-Ferrand and Lille university hospitals
Who may be able to join
- Pre-eclamptic patient according to the criteria defined by SFAR 2020.
- Indication of organised or semi-urgent cesarean section (Green or Orange code).
- Adult patient, benefiting from a social security system.
- Oral non-opposition to participation in the study.
Who cannot join
- Urgent Cesarean (Red code).
- Patient refusal.
- Patient does not understand French.
- Individual protection measures : guardianship, curatorship.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital, Clermont-Ferrand
Clermont-Ferrand, 63000
MARTINE BONNIN, +33 6-86-79-78-96, mbonnin@chu-clermontferrand.fr
GUILLAUME FERRAND, +33 6-11-35-71-82, gferrand@chu-clermontferrand.fr
About this study
Official title: Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients
Preeclampsia (PE) is an obstetric placental vascular pathology with a prevalence of 2 to 5% of pregnant women. It is defined by learned societies by the association of high blood pressure (BP≥140/90mmHg) and proteinuria \> 0.3g/day. The last French Maternal Mortality Report 2024 places cardiovascular complications among the main causes of maternal death. PE has an increasing number of deaths in 2016-2018 and significant preventability (66%).
Cesarean sections in pre-eclamptic patients are difficult procedures and, do not benefit from any specific recommendations. Cesarean section is promptly performed under regional anesthesia by spinal anesthesia or spinal anesthesia with combined epidural, techniques that cause maternal arterial hypotension with consequences for the baby.
Read more
These hypertensive patients, often on antihypertensives, challenge the anesthesiologist to manage the hemodynamic balance between the risk of arterial hypotension generated by the anesthesia corrected by vasoactive amines and the risk of major hypertension secondary to their management. The major risk in these patients with low platelet counts is hemorrhagic stroke.
Our study is an observational, bi-centric study between the maternity wards of the Clermont Ferrand and Lille University Hospitals.
It consists of collecting data prospectively on all pre-eclamptic patients undergoing a non-urgent cesarean section.
The objective is to observe the management of hemodynamics and calculate the prevalence of complications such as maternal hypotension and/or hypertension through the implementation of non-invasive monitoring (ClearSight).
Patients meeting the inclusion and non-inclusion criteria may be included in the study by an investigator after having given a non-opposition agreement after having received clear and fair information about the study.
In any case, the care of patients participating in the study will not be modified in any way compared to the usual practices of the services.
- Conditions
- Pre-eclampsia, Pre-Eclampsia, Severe
- Being tested
- Observational study to evaluate professional practices
- Keywords
- cesarean section, Blood pressure complications, pre-eclampsia, hypertension, hypotension
- Medical subject headings
- Pre-Eclampsia, Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study to evaluate professional practicesOther
It consists of collecting data prospectively on all pre-eclamptic patients undergoing a non-urgent cesarean section.
The objective is to observe the management of hemodynamics and calculate the prevalence of complications such as maternal hypotension and/or hypertension through the implementation of non-invasive monitoring (ClearSight).
| Study group | Role | What they receive |
|---|---|---|
| Lille University Hospital | Pre-eclamptic patients undergoing a cesarean section at the maternity ward of Lille University Hospital. Receives: Other: Observational study to evaluate professional practices | |
| Clermont-Ferrand University Hospital | Pre-eclamptic patients undergoing a cesarean section at the maternity ward of Clermont-Ferrand University Hospital. Receives: Other: Observational study to evaluate professional practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic events.
Prevalence of the occurrence of events such as maternal arterial hypotension and/or arterial hypertension during a cesarean section in a known pre-eclamptic patient.
Measured: During the entire cesarean procedure including anesthesia.
Secondary outcomes (5)
Duration of maternal hypotensive or hypertensive episodes.
Defined by the time-weighted average intraoperative PAS below a threshold of 110mmHg or above a threshold of 170mmHg. This measurement is commonly called TWA (Time Weighted Average), corresponding to the area between the chosen PAS threshold and the measured PAS curve, divided by the total measurement time.
Measured: During the entire cesarean procedure including anesthesia.
Number of maternal hypotensive and/or hypertensive episodes.
Measured: During the entire cesarean procedure including anesthesia.
Occurrence of major adverse events.
Measured: During the entire cesarean procedure including anesthesia.
Nature and dose of local anesthetic administered
Measured: During the entire cesarean procedure including anesthesia.
Nature and management of antihypertensive drugs during cesarean section.
Measured: During the entire cesarean procedure including anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Sep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- MARTINE BONNIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588023
- Sponsor's protocol ID
- M24BM0715
- Acronym
- HOPE
- Status last verified
- Aug 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients
- ClinicalTrials.gov ID
- NCT06588023
- Acronym / sponsor ID
- HOPE / M24BM0715
- Conditions
- Pre-eclampsia, Pre-Eclampsia, Severe
- Keywords
- cesarean section, Blood pressure complications, pre-eclampsia, hypertension, hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 5 Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Preeclampsia (PE) is an obstetric placental vascular pathology with a prevalence of 2 to 5% of pregnant women. It is defined by learned societies by the association of high blood pressure (BP≥140/90mmHg) and proteinuria \> 0.3g/day. The last French Maternal Mortality Report 2024 places cardiovascular complications among the main causes of maternal death. PE has an increasing number of deaths in 2016-2018 and significant preventability (66%).
Cesarean sections in pre-eclamptic patients are difficult procedures and, do not benefit from any specific recommendations. Cesarean section is promptly performed under regional anesthesia by spinal anesthesia or spinal anesthesia with combined epidural, techniques that cause maternal arterial hypotension with consequences for the baby.
These hypertensive patients, often on antihypertensives, challenge the anesthesiologist to manage the hemodynamic balance between the risk of arterial hypotension generated by the anesthesia corrected by vasoactive amines and the risk of major hypertension secondary to their management. The major risk in these patients with low platelet counts is hemorrhagic stroke.
Our study is an observational, bi-centric study between the maternity wards of the Clermont Ferrand and Lille University Hospitals.
It consists of collecting data prospectively on all pre-eclamptic patients undergoing a non-urgent cesarean section.
The objective is to observe the management of hemodynamics and calculate the prevalence of complications such as maternal hypotension and/or hypertension through the implementation of non-invasive monitoring (ClearSight).
Patients meeting the inclusion and non-inclusion criteria may be included in the study by an investigator after having given a non-opposition agreement after having received clear and fair information about the study.
In any case, the care of patients participating in the study will not be modified in any way compared to the usual practices of the services.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lille University Hospital | – | Other: Observational study to evaluate professional practicesPre-eclamptic patients undergoing a cesarean section at the maternity ward of Lille University Hospital. |
| Clermont-Ferrand University Hospital | – | Other: Observational study to evaluate professional practicesPre-eclamptic patients undergoing a cesarean section at the maternity ward of Clermont-Ferrand University Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-eclamptic patients undergoing cesarean section in the maternity wards of the Clermont-Ferrand and Lille university hospitals
Key inclusion criteria (4 listed)
- Pre-eclamptic patient according to the criteria defined by SFAR 2020.
- Indication of organised or semi-urgent cesarean section (Green or Orange code).
- Adult patient, benefiting from a social security system.
- Oral non-opposition to participation in the study.
Key exclusion criteria (4 listed)
- Urgent Cesarean (Red code).
- Patient refusal.
- Patient does not understand French.
- Individual protection measures : guardianship, curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study to evaluate professional practicesIt consists of collecting data prospectively on all pre-eclamptic patients undergoing a non-urgent cesarean section. The objective is to observe the management of hemodynamics and calculate the prevalence of complications such as maternal hypotension and/or hypertension through the implementation of non-invasive monitoring (ClearSight). | Other | Clermont-Ferrand University Hospital, Lille University Hospital |
Primary outcome
Hemodynamic events.
Time frame: During the entire cesarean procedure including anesthesia.
Prevalence of the occurrence of events such as maternal arterial hypotension and/or arterial hypertension during a cesarean section in a known pre-eclamptic patient.
5 secondary outcomes
Duration of maternal hypotensive or hypertensive episodes.
Time frame: During the entire cesarean procedure including anesthesia.
Number of maternal hypotensive and/or hypertensive episodes.
Time frame: During the entire cesarean procedure including anesthesia.
Occurrence of major adverse events.
Time frame: During the entire cesarean procedure including anesthesia.
Nature and dose of local anesthetic administered
Time frame: During the entire cesarean procedure including anesthesia.
Nature and management of antihypertensive drugs during cesarean section.
Time frame: During the entire cesarean procedure including anesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Pre-eclampsia
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Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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. This study is not recruiting at the moment.
MARTINE BONNIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-eclampsia and Pre-Eclampsia, Severe, run by University Hospital, Clermont-Ferrand at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BONNIN (+33 6-86-79-78-96, mbonnin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic events. (time frame: During the entire cesarean procedure including anesthesia.). 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 19 Sep 2024.