Studies

Observational Not yet recruiting

NCT07759024 on ClinicalTrials.gov

Cesarean Delivery Outcomes in Maternal Critical Care

Official title: Maternal and Fetal Prognosis of Cesarean Delivery in Critically Ill Patients

  • Sponsor: Société Française d’Anesthésie et de Réanimation
  • Enrollment: 200 (Estimated)
  • Study start: 2026-10-01 (Estimated)
  • Primary completion: 2027-12-31 (Estimated)
  • Study completion: 2027-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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.

Conditions

  • Delivery Complication
  • Pregnancy Related

Primary Outcome Measures

  • Maternal mortality (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.