Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients (HOPE)

NCT06588023 | Not Yet Recruiting

• 1 other identifier: M24BM0715
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pre-eclampsia; Pre-Eclampsia, Severe

Keywords

cesarean section; Blood pressure complications; pre-eclampsia; hypertension; hypotension

Outcome Measures

Primary Outcomes (1)

• 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.

  During the entire cesarean procedure including anesthesia.

Secondary Outcomes (5)

• Duration of maternal hypotensive or hypertensive episodes.

  During the entire cesarean procedure including anesthesia.

• Number of maternal hypotensive and/or hypertensive episodes.

  During the entire cesarean procedure including anesthesia.

• Occurrence of major adverse events.

  During the entire cesarean procedure including anesthesia.

• Nature and dose of local anesthetic administered

  During the entire cesarean procedure including anesthesia.

• Nature and management of antihypertensive drugs during cesarean section.

  During the entire cesarean procedure including anesthesia.

Other Outcomes (3)

• Maximum dosages and cumulative doses of Noradrenaline during cesarean section.

  During the entire cesarean procedure including anesthesia.

• Total vascular filling volume.

  During the entire cesarean procedure including anesthesia.

• Total diuresis.

  During the entire cesarean procedure including anesthesia.

Study Arms (2)

Lille University Hospital

Pre-eclamptic patients undergoing a cesarean section at the maternity ward of Lille University Hospital.

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.

Other: Observational study to evaluate professional practices

Interventions

Observational study to evaluate professional practices OTHER

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).

Clermont-Ferrand University Hospital; Lille University Hospital

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

Pre-eclamptic patients undergoing cesarean section in the maternity wards of the Clermont-Ferrand and Lille university hospitals

You may qualify if:

• 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.

You may not qualify if:

• Urgent Cesarean (Red code).
• Patient refusal.
• Patient does not understand French.
• Individual protection measures : guardianship, curatorship.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• University Hospital, Lille: collaborator

Study Sites (1)

University Hospital, Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension; Hypotension

Condition Hierarchy (Ancestors)

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

Study Officials

• MARTINE BONNIN

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BONNIN

CONTACT

+33 6-86-79-78-96; mbonnin@chu-clermontferrand.fr

GUILLAUME FERRAND

CONTACT

+33 6-11-35-71-82; gferrand@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 5, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

FR (1)