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NCT Number: NCT06588023

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Duration of maternal hypotensive or hypertensive episodes.

    Time frame: During the entire cesarean procedure including anesthesia.

    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.

  2. Number of maternal hypotensive and/or hypertensive episodes.

    Time frame: During the entire cesarean procedure including anesthesia.

  3. Occurrence of major adverse events.

    Time frame: During the entire cesarean procedure including anesthesia.

  4. Nature and dose of local anesthetic administered

    Time frame: During the entire cesarean procedure including anesthesia.

  5. Nature and management of antihypertensive drugs during cesarean section.

    Time frame: During the entire cesarean procedure including anesthesia.

Other outcomes

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

    Time frame: During the entire cesarean procedure including anesthesia.

  2. Total vascular filling volume.

    Time frame: During the entire cesarean procedure including anesthesia.

  3. Total diuresis.

    Time frame: During the entire cesarean procedure including anesthesia.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • University Hospital, Lille

Registry information

Official study title

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

Acronym: HOPE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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