Organ Dysfunction Score for Obstetric Patients
Launched by DANIELA VASQUEZ · Jul 6, 2025
Trial Information
Current as of July 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to measure how well organs are working in women who are pregnant or have just given birth and need care in an intensive care unit (ICU). Doctors currently use a scoring system called SOFA to check for organ problems and predict how patients might do, but this score doesn’t take into account the normal changes that happen during pregnancy and right after birth. This study aims to create and test a version of this score, called SOFA-OBS, that is adjusted for these changes. The study will also see if using a simple, painless device that measures oxygen levels through the skin (a pulse oximeter) can be as helpful as the usual method, which involves a blood test from an artery and can be uncomfortable.
Women who are pregnant at any stage or up to three days after giving birth, who are 18 or older, and who need to stay in the ICU for at least a day may be eligible to take part. If they agree, the study will only collect information and test results that doctors normally use during ICU care—no extra procedures or treatments are required. The goal is to develop a better tool to help doctors quickly spot serious problems and treat them early, which could improve outcomes and save lives for mothers in critical condition.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • Any of the following=
- • Patients \<18 years old
- • Non-pregnant patients
- • ≥ 4 days postpartum
- • Patients or surrogates not giving consent to participate
- • ICU-LOS \< 24 h
About Daniela Vasquez
Daniela Vasquez is a clinical trial sponsor dedicated to advancing medical research through the support and oversight of innovative clinical studies. With a strong commitment to ethical standards and patient safety, she facilitates the development of new therapies and interventions aimed at improving health outcomes. Her leadership in coordinating multidisciplinary teams ensures rigorous trial design and execution, contributing to the generation of high-quality clinical evidence.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Avellaneda, Buenos Aires, Argentina
City Of Buenos Aires, Buenos Aires, Argentina
Florencio Varela, Buenos Aires, Argentina
González Catán, Buenos Aires, Argentina
San Martín, Buenos Aires, Argentina
San Martín, Buenos Aires, Argentina
Tigre, Buenos Aires, Argentina
City Of Buenos Aires, , Argentina
City Of Buenos Aires, , Argentina
City Of Buenos Aires, , Argentina
La Rioja, , Argentina
Mendoza, , Argentina
San Luis, , Argentina
Santiago Del Estero, , Argentina
Quito, , Ecuador
San Salvador, , El Salvador
Montevideo, , Uruguay
Patients applied
Trial Officials
Daniela N. Vasquez, MD
Principal Investigator
Sanatorio Anchorena Recoleta
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported