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Cesarean Delivery Outcomes in Maternal Critical Care

Maternal and Fetal Prognosis of Cesarean Delivery in Critically Ill Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07759024
Acronym
CESAREA
Enrollment
200
Registered
2026-08-11
Start date
2026-10-01
Completion date
2027-12-31
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Complication, Pregnancy Related

Brief summary

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.

Detailed description

Cesarean delivery performed in critically ill pregnant women, particularly outside the operating room (OR), represents a rare but extremely high-risk clinical situation for both mother and fetus. These patients are admitted to intensive care units (ICUs) because of severe maternal conditions such as hypertensive disorders of pregnancy, hemorrhagic shock, acute respiratory failure, severe infections, or major trauma. Although these conditions have been extensively described in the critical care obstetric literature, data specifically addressing cesarean delivery performed outside the operating room remain scarce. In life-threatening situations, emergency cesarean delivery may be required to preserve maternal and/or fetal life and may be performed directly in the ICU, high-dependency unit, emergency department, or even in the prehospital setting. Such situations have mainly been described in maternal cardiac arrest, perimortem cesarean delivery, severe trauma, and catastrophic maternal deterioration. Women requiring cesarean delivery outside the operating room frequently present with multiple organ failure requiring advanced organ support, including prolonged mechanical ventilation, vasopressor therapy, renal replacement therapy, or extracorporeal membrane oxygenation (ECMO). These critically ill obstetric patients experience higher rates of hemorrhagic complications, nosocomial infections, prolonged ICU stay, and maternal mortality than women delivering in conventional obstetric settings. Furthermore, non-operating room environments are not specifically designed for obstetric surgery, creating additional challenges regarding sterility, multidisciplinary coordination, hemodynamic management, anesthesia, and thromboembolic prevention. Neonatal outcomes are also of major concern. Emergency fetal extraction frequently results in iatrogenic prematurity, increasing the risk of respiratory distress syndrome, perinatal asphyxia, severe neonatal infection, and prolonged admission to the neonatal intensive care unit (NICU). Neonatal prognosis mainly depends on gestational age at delivery and maternal hemodynamic stability. Current evidence is limited to case reports, small observational studies, or cohorts restricted to specific etiologies such as trauma, severe infection, or COVID-19. A large nationwide registry is therefore needed to better characterize maternal and fetal outcomes associated with cesarean delivery outside the operating room and to identify factors associated with poor prognosis. Improved knowledge of this rare clinical scenario may contribute to the development of organizational protocols, simulation programs, cognitive aids, and ultimately evidence-based recommendations for the management of critically ill pregnant women. The limitations inherent to this registry should nevertheless be acknowledged, including the rarity of events, the long inclusion period, and changes in clinical practice over time. Primary Objective To evaluate the association between cesarean delivery performed outside the operating room and maternal mortality among critically ill pregnant women by comparing women undergoing cesarean delivery outside the operating room with those undergoing cesarean delivery in the operating room.

Interventions

None listed

Sponsors

Société Française d'Anesthésie et de Réanimation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

Inclusion criteria

* Women aged ≥18 years. * Pregnancy ≥22 weeks of gestation. * Admission (or planned admission) to a critical care unit.

Exclusion criteria

* Age \<18 years. * Objection to the use of medical data. * Patients under legal protection (guardianship or similar legal measures).

Design outcomes

Primary

MeasureTime frameDescription
Maternal mortalityduring pregnancy or within 42 days after the end of pregnancyMaternal 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.

Secondary

MeasureTime frameDescription
Incidenceup to deliveryIncidence and temporal trends of cesarean deliveries performed outside the operating room
Description of the organisational arrangements for performing caesarean sections outside the operating roomup to delivery• 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.
•Maternal adverse outcomes (observed or not)peri and post deliveryincluding * 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)
Neonatal mortalityDay 28Neonatal mortality at Day 28.
Neonatal adverse outcomesduring hospitalizationEvaluation will be presence or not of neonatal adverse outcomes. The Adverse outcomes includes: * neonatal death; * severe perinatal asphyxia; * Apgar scores; * umbilical arterial pH \<7.0; * severe neonatal complications; * prolonged (\>48 h) NICU admission.
cesarean delivery and maternal comorbiditiesBaseline, before deliveryIndications for cesarean delivery and maternal comorbidities

Contacts

CONTACTVincent LEGROS, MD
vlegros@chu-reims.fr+33 03 26 78 30 21
CONTACTEmilie RAIMOND, MD
eraimond@chu-reims.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026