Advanced Wireless Sensors for Neonatal Care in the Delivery Room
NCT06693817
Apnea of Newborn, Asphyxia Neonatorum
Londrina, Paraná, Brazil
View Trial DetailsNCT Number: NCT07759024
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to delivery
Incidence and temporal trends of cesarean deliveries performed outside the operating room
Time frame: up to delivery
Time frame: peri and post delivery
including
Time frame: Day 28
Neonatal mortality at Day 28.
Time frame: during hospitalization
Evaluation will be presence or not of neonatal adverse outcomes. The Adverse outcomes includes:
Time frame: Baseline, before delivery
Indications for cesarean delivery and maternal comorbidities
Contact information is provided by the study sponsor or research team.
Emilie RAIMOND, MD
CONTACT
Vincent LEGROS, MD
CONTACT
Société Française d'Anesthésie et de Réanimation
Other
Maternal and Fetal Prognosis of Cesarean Delivery in Critically Ill Patients
Acronym: CESAREA
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.
Published trials that share one or more normalized conditions with this study.
NCT06693817
Apnea of Newborn, Asphyxia Neonatorum
Londrina, Paraná, Brazil
View Trial DetailsNCT05080309
Delivery Complication, Labor Long
Caen, France
View Trial DetailsNCT05258786
Delivery Complication, Pregnancy Related
Ariel, Israel
View Trial DetailsNCT06970483
Cesarean Section Complications, Delivery Complication
Ankara, Turkey (Türkiye)
View Trial Details