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NCT Number: NCT07759024

Cesarean Delivery Outcomes in Maternal Critical Care

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

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

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).

Treatment and study plan

Primary outcomes

  1. Maternal mortality

    Time frame: during pregnancy or within 42 days after the end of pregnancy

    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.

Secondary outcomes

  1. Incidence

    Time frame: up to delivery

    Incidence and temporal trends of cesarean deliveries performed outside the operating room

  2. Description of the organisational arrangements for performing caesarean sections outside the operating room

    Time frame: up 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.
  3. •Maternal adverse outcomes (observed or not)

    Time frame: peri and post delivery

    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)
  4. Neonatal mortality

    Time frame: Day 28

    Neonatal mortality at Day 28.

  5. Neonatal adverse outcomes

    Time frame: during hospitalization

    Evaluation 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.
  6. cesarean delivery and maternal comorbidities

    Time frame: Baseline, before delivery

    Indications for cesarean delivery and maternal comorbidities

Study contacts

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

Emilie RAIMOND, MD

CONTACT

[email protected]

Vincent LEGROS, MD

CONTACT

[email protected]

+33 03 26 78 30 21

Sponsors and collaborators

Lead sponsor

Société Française d'Anesthésie et de Réanimation

Other

Registry information

Official study title

Maternal and Fetal Prognosis of Cesarean Delivery in Critically Ill Patients

Acronym: CESAREA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

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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