Cesarean Delivery Outcomes in Maternal Critical Care
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSociété Française d'Anesthésie et de Réanimation
About this trial
Cesarean delivery in critically ill pregnant women, especially outside the operating room, is a rare but high-risk situation for both mother and fetus. These patients often suffer from severe conditions (hypertensive disorders, hemorrhage, respiratory failure, infection, or trauma) and may require emergency cesarean in the ICU, emergency department, or prehospital setting.
They frequently need advanced organ support and face higher rates of complications, prolonged ICU stay, and maternal mortality. Non-OR environments also create challenges in sterility, coordination, and management. Neonatal outcomes are often impaired by iatrogenic prematurity.
Current evidence is limited. A large nationwide registry is needed to better describe outcomes and support future protocols and recommendations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged ≥18 years.
Pregnancy ≥22 weeks of gestation.
Admission (or planned admission) to a critical care unit.
Disqualifiers
Age <18 years.
Objection to the use of medical data.
Patients under legal protection (guardianship or similar legal measures).
Trial population
Pregnant women (≥22 weeks of gestation) admitted to an intensive care unit or high-dependency unit.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 3 trial groupsGroup A: Study group:
Group B: Comparison group
Group C: Descriptive subgroup:
Trial outcomes
Primary outcomes
1
Maternal mortality
Maternal mortality, defined according to the ICD-10 classification as any death occurring during pregnancy or within 42 days after the end of pregnancy from any cause related to or aggravated by the pregnancy or its management, excluding accidental or incidental causes. The end of pregnancy will be defined as the date of cesarean delivery or vaginal delivery. Women dying before delivery will be considered as maternal deaths occurring during pregnancy.
Time frame
during pregnancy or within 42 days after the end of pregnancySecondary outcomes
1
Incidence
Incidence and temporal trends of cesarean deliveries performed outside the operating room
Time frame
up to delivery2
Description of the organisational arrangements for performing caesarean sections outside the operating room
• Organizational characteristics including: * hospital type (university hospital, general hospital, private hospital); * type of critical care unit; * ICU size; * specialty of the surgeon performing the cesarean delivery; * decision-to-incision and incision-to-delivery intervals; * need for intra- or interhospital transfer; * availability and level of maternity services; * availability of neonatal intensive care facilities.
Time frame
up to delivery3
•Maternal adverse outcomes (observed or not)
including * maternal death (y/n); * major complications (y/n); * acute respiratory distress syndrome (ARDS) (y/n); * shock (y/n); * hemorrhagic complications (y/n); * nosocomial infections (y/n)
Time frame
peri and post delivery4
Neonatal mortality
Neonatal mortality at Day 28.
Time frame
Day 28Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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