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Not yet recruitingNCT07759024CESAREAUpdated Aug 11, 2026

Cesarean Delivery Outcomes in Maternal Critical Care

An observational study in Delivery Complication and Pregnancy Related, sponsored by Société Française d'Anesthésie et de Réanimation. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Société Française d'Anesthésie et de Réanimation · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Delivery Complication
  • Pregnancy Related
03

In context

Lead sponsor

Société Française d'Anesthésie et de Réanimation is the lead sponsor of 18 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years.
  • Objection to the use of medical data.
  • Patients under legal protection (guardianship or similar legal measures).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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 pregnancy

Secondary outcomes

  1. Incidence

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

    Time frame: up to delivery

  2. 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 delivery

  3. •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 delivery

  4. Neonatal mortality

    Neonatal mortality at Day 28.

    Time frame: Day 28

  5. Neonatal adverse outcomes

    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.

    Time frame: during hospitalization

  6. cesarean delivery and maternal comorbidities

    Indications for cesarean delivery and maternal comorbidities

    Time frame: Baseline, before delivery

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2026
First posted
Aug 11, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07759024
Lead sponsor
Société Française d'Anesthésie et de Réanimation
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Vincent LEGROS, MD
Contact
vlegros@chu-reims.fr
+33 03 26 78 30 21
Emilie RAIMOND, MD
Contact
eraimond@chu-reims.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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