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Development and Validation of an Obstetric Organ Dysfunction Score to Predict Mortality in Intensive Care Unit: A Multicenter, Prospective, Cohort Study

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

Background: When managing severely ill patients in ICU, the investigators often use what it is called scores. Scores refer to a numerical value assigned to a patient's condition, which often predict outcome. The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assess severity of organ dysfunction (in liver, kidney, blood pressure, respiratory, neurologic and platelets). It also identifies patients with severe infections (sepsis) and patients with bad outcomes. Patients undergoing pregnancy or early postpartum develop physiological changes, such us a decrease in creatinine (a laboratory test measuring kidney function) and a decrease in blood pressure during the second trimester. These changes are not considered by the SOFA score. Actually, there is not an organ dysfunction score adapted to pregnant/postpartum patients to be used in the ICU. Moreover, a blood sample taken by arterial puncture is required to evaluate respiratory function by the SOFA score, which is a painful procedure. Instead, the investigators could evaluate respiratory function using a pulse oximeter, which measures peripheral oxygen saturation without needing an arterial puncture. Potential benefits: A SOFA-OBS would hopefully become a more precise tool than general SOFA to evaluate organ dysfunction and to predict outcome among these patients. It would also help to detect sepsis earlier and treat it promptly, which might help reducing its mortality.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ All of the following=

• Pregnant (at any gestational age) or post-partum patients (at ≤3 days postpartum)

• ≥ 18 years old

• Requiring admission to ICU for any reason

• Staying in the ICU for ≥ 24h

• Giving her consent to participate. Patients will be recruited consecutively until reaching the sample size.

Locations
Other Locations
Argentina
Sanatorio Itoiz
RECRUITING
Avellaneda
Hospital Cuenca Alta Néstor Kirchner
RECRUITING
Canuelas
Sanatorio Anchorena Recoleta
RECRUITING
City Of Buenos Aires
Sanatorio Antártida
NOT_YET_RECRUITING
City Of Buenos Aires
Sanatorio Finochietto
NOT_YET_RECRUITING
City Of Buenos Aires
Sanatorio Guemes
RECRUITING
City Of Buenos Aires
Hospital Simplemente Evita
RECRUITING
González Catán
Hospital de la Madre y el Niño
RECRUITING
La Rioja
Hospital Regional Diego Paroissien
NOT_YET_RECRUITING
Mendoza
Hospital Mi Pueblo Florencio Varela
RECRUITING
San Juan Bautista
Maternidad Provincial Teresita Baigorria
NOT_YET_RECRUITING
San Luis
Hospital Thompson
RECRUITING
San Martín
Sanatorio Anchorena San Martín
RECRUITING
San Martín
Hospital Regional Ramón Carrillo
NOT_YET_RECRUITING
Santiago Del Estero
Hospital Materno Infantil Dr. F Escardó
RECRUITING
Tigre
Ecuador
Hospital Gineco Obstétrico Isidro Ayora
RECRUITING
Quito
El Salvador
Hospital Materno Infantil 1 de mayo
NOT_YET_RECRUITING
San Salvador
Uruguay
Hospital de Clínicas Dr. Manuel Quintela
NOT_YET_RECRUITING
Montevideo
Contact Information
Primary
Daniela N. Vasquez, MD
danielavasquez73@gmail.com
+5492215041762
Backup
Andrea V. Das Neves, MD
av.dasneves@gmail.com
+5492215792555
Time Frame
Start Date: 2025-10-06
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 130
Treatments
Obstetric patients= pregnant and postpartum (< 3 days) patients requiring ICU admission
All pregnant and postpartum (\< 3 days) patients requiring ICU admission will be followed during their ICU-LOS. The predictive validity for ICU mortality of an adjusted to obstetric patients Sequential Organ Failure Assessment (SOFA-OBS) score will be compared to the predictive validity of a non-modified Sequential Organ Failure Assessment (SOFA) score.
Related Therapeutic Areas
Sponsors
Leads: Daniela Vasquez

This content was sourced from clinicaltrials.gov