The Periviable GOALS Decision Support Tool
Recruiting now · Not applicable
Conditions studied: Pregnancy Preterm, Premature Birth, Pregnancy Complications, Obstetric Labor, Premature, Obstetric Labor Complications
In brief
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.
Key facts
- Study ID
- NCT05264779
- Run by
- Indiana University
- People needed
- 300
- Starts
- 2022-06-06
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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)
Where it is running
- The University of Texas at Austin — Austin, Texas, United States (enrolling)
- University of California San Francisco — San Francisco, California, United States (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Indiana University — Indianapolis, Indiana, United States (enrolling)
- The University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
- The University of Kentucky — Lexington, Kentucky, United States (enrolling)
- University of Massachusetts — Worcester, Massachusetts, United States (enrolling)
- The Ohio State University — Columbus, Ohio, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- The University of California San Diego — San Diego, California, United States (enrolling)
- Brown University — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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