The Periviable GOALS Decision Support Tool

Recruiting

Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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)

About the study

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.

What is being tested

Periviable GOALS DST (other)

Sponsor: Indiana University · Participants: 300 · Started: Jun 6, 2022

Contact the study team

Shelley Hoffman, MPH · Phone: 3172789636

Official record on ClinicalTrials.gov — NCT05264779

Locations in the U.S.

California	The University of California San Diego, San Diego University of California San Francisco, San Francisco
Connecticut	Yale University, New Haven
Illinois	Northwestern University, Chicago
Indiana	Indiana University, Indianapolis
Kansas	The University of Kansas Medical Center, Kansas City
Kentucky	The University of Kentucky, Lexington
Massachusetts	University of Massachusetts, Worcester
Ohio	The Ohio State University, Columbus
Pennsylvania	University of Pennsylvania, Philadelphia
Rhode Island	Brown University, Providence (Not yet recruiting)
Texas	The University of Texas at Austin, Austin

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.