Cesarean Delivery Outcomes in Maternal Critical Care

NCT07759024 | Not Yet Recruiting

• 1 other identifier: CESAREA / 2025-05
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

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.

  during pregnancy or within 42 days after the end of pregnancy

Secondary Outcomes (6)

• Incidence

  up to delivery

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

  up to delivery

• •Maternal adverse outcomes (observed or not)

  peri and post delivery

• Neonatal mortality

  Day 28

• Neonatal adverse outcomes

  during hospitalization

Study Arms (3)

Study group:

• Study group: cesarean delivery performed outside the operating room (ICU, high-dependency unit, emergency department, or prehospital setting).

Comparison group

• Comparison group: women admitted to critical care without cesarean delivery outside the operating room, including: * cesarean delivery performed in the operating room; * women who did not undergo cesarean delivery.

Descriptive subgroup:

• Descriptive subgroup: women who died during pregnancy (≥22 weeks of gestation) without undergoing cesarean delivery.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women (≥22 weeks of gestation) admitted to an intensive care unit or high-dependency unit.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women (≥22 weeks of gestation) admitted to an intensive care unit or high-dependency unit.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Société Française d'Anesthésie et de Réanimation: lead

Central Study Contacts

Vincent LEGROS, MD

CONTACT

+33 03 26 78 30 21; vlegros@chu-reims.fr

Emilie RAIMOND, MD

CONTACT

eraimond@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08