Delivery ComplicationCESAREANCT07759024
Cesarean Delivery Outcomes in Maternal Critical Care
An observational study of Delivery Complication and Pregnancy Related, run by Société Française d'Anesthésie et de Réanimation.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delivery Complication, Pregnancy Related
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Pregnant women (≥22 weeks of gestation) admitted to an intensive care unit or high-dependency unit.
Who may be able to join
- Women aged ≥18 years.
- Pregnancy ≥22 weeks of gestation.
- Admission (or planned admission) to a critical care unit.
Who cannot join
- Age <18 years.
- Objection to the use of medical data.
- Patients under legal protection (guardianship or similar legal measures).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Emilie RAIMOND, MD contact
About this study
Official title: Maternal and Fetal Prognosis of Cesarean Delivery in Critically Ill Patients
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.
- Conditions
- Delivery Complication, Pregnancy Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during pregnancy or within 42 days after the end of pregnancy
Secondary outcomes (6)
Incidence
Incidence and temporal trends of cesarean deliveries performed outside the operating room
Measured: up to delivery
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.
Measured: up to delivery
•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)
Measured: peri and post delivery
Neonatal mortality
Neonatal mortality at Day 28.
Measured: Day 28
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.
Measured: during hospitalization
cesarean delivery and maternal comorbidities
Indications for cesarean delivery and maternal comorbidities
Measured: Baseline, before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Française d'Anesthésie et de Réanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759024
- Sponsor's protocol ID
- CESAREA / 2025-05
- Acronym
- CESAREA
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Fetal Prognosis of Cesarean Delivery in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07759024
- Acronym / sponsor ID
- CESAREA / CESAREA / 2025-05
- Conditions
- Delivery Complication, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Société Française d'Anesthésie et de RéanimationUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant women (≥22 weeks of gestation) admitted to an intensive care unit or high-dependency unit.
Key inclusion criteria (3 listed)
- Women aged ≥18 years.
- Pregnancy ≥22 weeks of gestation.
- Admission (or planned admission) to a critical care unit.
Key exclusion criteria (3 listed)
- Age <18 years.
- Objection to the use of medical data.
- Patients under legal protection (guardianship or similar legal measures).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Incidence
Time frame: up to delivery
Description of the organisational arrangements for performing caesarean sections outside the operating room
Time frame: up to delivery
•Maternal adverse outcomes (observed or not)
Time frame: peri and post delivery
Neonatal mortality
Time frame: Day 28
Neonatal adverse outcomes
Time frame: during hospitalization
cesarean delivery and maternal comorbidities
Time frame: Baseline, before delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
Related trials for Delivery Complication
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilie RAIMOND, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Delivery Complication and Pregnancy Related, run by Société Française d'Anesthésie et de Réanimation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent LEGROS, MD (+33 03 26 78 30 21, vlegros@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal mortality (time frame: during pregnancy or within 42 days after the end of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.