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โ† Trials
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The Periviable GOALS Decision Support Tool

RecruitingNAAges 18 Years - anyAllIndiana University
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In plain words

What the trial is, and whether it could suit you

The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria for Pregnant Persons: * Adults (18 years or older) * Pregnant between 22 0/7 to 25 6/7 weeks gestation (this window may be slightly different for each recruitment site, as the gestational window that defines periviable delivery varies by institution). * Presenting to Labor \& Delivery at an approved study site with a pregnancy complication that poses the potential threat of or need for periviable delivery (e.g., rupture of membranes, preterm labor, shortened cervix, pre-eclampsia, and growth restriction). * Must have been counseled on their neonatal treatment options (e.g. resuscitation, comfort care) by their healthcare team prior to being approached by the study team. Inclusion Criteria for Important Others: * Adults (18 years or older) * 1 per pregnant person * Is identified by the pregnant person as someone who will be involved in making decisions for the baby * Must be present at the time of randomization to participate Exclusion Criteria: * Under 18 years of age * Incarcerated * Medically unstable (i.e. in active labor and dilated 6cm or more) * Emotionally unstable * Have not been counseled by their healthcare team regarding neonatal treatment options * Are not admitted to Labor \& Delivery for reasons indicative of a threatened early delivery * If they are experiencing a known fatal fetal anomaly * Are not present at the time of randomization (only for important others)
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What it tests

  • Periviable GOALS DST
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Where

12 sites
The University of California San Diego
San Diego, United States
University of California San Francisco
San Francisco, United States
Yale University
New Haven, United States
Northwestern University
Chicago, United States
Indiana University
Indianapolis, United States
The University of Kansas Medical Center
Kansas City, United States
The University of Kentucky
Lexington, United States
University of Massachusetts
Worcester, United States

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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