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Search / Trial NCT07068022

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

Sequential Organ Failure Assessment Score Pregnancy Postpartum Critical Care Intensive Care Unit Creatinine Peripheral Oxygen Saturation Hypotension Maternal Mortality Mortality Sepsis Septic Shock Multicenter Study

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.

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

0 patients applied

Trial Officials

Daniela N. Vasquez, MD

Principal Investigator

Sanatorio Anchorena Recoleta

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported