The Periviable GOALS Decision Support Tool

Launched by INDIANA UNIVERSITY · Mar 2, 2022

Keywords

ClinConnect Summary

The Periviable GOALS clinical trial is studying a decision support tool designed to help families make informed choices about neonatal resuscitation when facing a very early delivery, which is when a baby is born between 22 to 25 weeks of pregnancy. This tool aims to provide clear information about the possible outcomes for the baby and assist families in understanding their options. It's important to note that this tool is meant to work alongside discussions with healthcare providers, not replace them. The researchers believe that using this tool will lead to better decision-making and greater satisfaction with the choices made during such a challenging time.

To participate in the trial, pregnant individuals must be at least 18 years old and experiencing complications that could lead to a very early delivery. They need to be between 22 and 25 weeks pregnant and have already discussed their treatment options with their healthcare team. Additionally, one person identified by the pregnant individual who will help make decisions for the baby can also join the study. Participants can expect to use the decision support tool independently, while receiving guidance and support throughout the process. This trial is currently recruiting participants and aims to improve the support families receive during these critical moments.

Gender

ALL

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)