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New scoring system could save lives of pregnant women in ICU

NCT ID NCT07068022

Knowledge-focused Sponsor: Daniela Vasquez Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to create a new scoring system (SOFA-OBS) that better predicts death risk for pregnant and postpartum women in intensive care. Researchers will collect routine data from 130 patients and test if a simple pulse oximeter can replace painful blood draws. The goal is to improve early detection of organ failure and sepsis, potentially saving more lives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients will be recruited in ICUs from third level hospitals from Latin American countries.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hypotensive disorder infectious disease with sepsis Maternal Death puerperal disorder Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical care, intensive care Organ dysfunction Postpartum Pregnancy Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Cuenca Alta Néstor Kirchner

    RECRUITING

    Canuelas, Buenos Aires, Argentina

  • Hospital Gineco Obstétrico Isidro Ayora

    RECRUITING

    Quito, Ecuador

  • Hospital Materno Infantil 1 de mayo

    NOT_YET_RECRUITING

    San Salvador, El Salvador

  • Hospital Materno Infantil Dr. F Escardó

    RECRUITING

    Tigre, Buenos Aires, Argentina

  • Hospital Mi Pueblo Florencio Varela

    RECRUITING

    San Juan Bautista, Buenos Aires, Argentina

  • Hospital Regional Diego Paroissien

    NOT_YET_RECRUITING

    Mendoza, Mendoza Province, Argentina

  • Hospital Regional Ramón Carrillo

    NOT_YET_RECRUITING

    Santiago del Estero, Santiago del Estero Province, Argentina

  • Hospital Simplemente Evita

    RECRUITING

    González Catán, Buenos Aires, Argentina

  • Hospital Thompson

    RECRUITING

    San Martín, Buenos Aires, Argentina

  • Hospital de Clínicas Dr. Manuel Quintela

    NOT_YET_RECRUITING

    Montevideo, Uruguay

  • Hospital de la Madre y el Niño

    RECRUITING

    La Rioja, La Rioja Province, Argentina

  • Maternidad Provincial Teresita Baigorria

    NOT_YET_RECRUITING

    San Luis, San Luis Province, Argentina

  • Sanatorio Anchorena Recoleta

    RECRUITING

    City of Buenos Aires, Buenos Aires, 1894, Argentina

  • Sanatorio Anchorena San Martín

    RECRUITING

    San Martín, Buenos Aires, Argentina

  • Sanatorio Antártida

    NOT_YET_RECRUITING

    City of Buenos Aires, Argentina

  • Sanatorio Finochietto

    NOT_YET_RECRUITING

    City of Buenos Aires, Argentina

  • Sanatorio Guemes

    RECRUITING

    City of Buenos Aires, Argentina

  • Sanatorio Itoiz

    RECRUITING

    Avellaneda, Buenos Aires, Argentina

More trials for these conditions

Other studies related to the condition(s) this trial covers.