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Recruiting NCT05264779

The Periviable GOALS Decision Support Tool

Conditions: Pregnancy Preterm, Premature Birth, Pregnancy Complications, Obstetric Labor, Premature, Obstetric Labor Complications

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Indiana University

Location: The University of California San Diego San Diego California

Summary

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.

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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05264779). StuddyBuddy aggregates publicly available trial information.