A decision support tool for families facing preterm delivery decisions

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

This study is testing a new tool to help families make better decisions about care for their premature babies born between 22 and 26 weeks of pregnancy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (other)
• Locations: 12 sites (San Diego, California and 11 other locations)
• Trial ID: NCT05264779 on ClinicalTrials.gov

What this trial studies

The Periviable GOALS decision support tool is designed to aid families in making informed decisions regarding neonatal resuscitation during periviable deliveries, which occur between 22 0/7 and 25 6/7 weeks of gestation. This multisite, randomized controlled trial will involve 144 pregnant patients who are hospitalized due to complications threatening preterm delivery. Participants will be randomized into treatment and control groups, with data collected through baseline questionnaires and surveys before delivery. The tool aims to enhance shared decision-making and improve satisfaction with the decision-making process.

Who should consider this trial

Good fit: Ideal candidates are pregnant individuals aged 18 or older, between 22 0/7 and 25 6/7 weeks gestation, facing complications that may lead to preterm delivery.

Not a fit: Patients who are under 18 years old or not facing a periviable delivery situation may not benefit from this study.

Why it matters

Potential benefit: If successful, this tool could empower families to make more informed and satisfactory decisions regarding neonatal care during critical preterm delivery situations.

How similar studies have performed: Other studies have shown promise in using decision support tools for similar patient populations, indicating potential for success with this approach.

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)

Where this trial is running

San Diego, California and 11 other locations

• The University of California San Diego — San Diego, California, United States (RECRUITING)
• University of California San Francisco — San Francisco, California, United States (RECRUITING)
• Yale University — New Haven, Connecticut, United States (RECRUITING)
• Northwestern University — Chicago, Illinois, United States (RECRUITING)
• Indiana University — Indianapolis, Indiana, United States (RECRUITING)
• The University of Kansas Medical Center — Kansas City, Kansas, United States (RECRUITING)
• The University of Kentucky — Lexington, Kentucky, United States (RECRUITING)
• University of Massachusetts — Worcester, Massachusetts, United States (RECRUITING)
• The Ohio State University — Columbus, Ohio, United States (RECRUITING)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
• Brown University — Providence, Rhode Island, United States (NOT_YET_RECRUITING)
• The University of Texas at Austin — Austin, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Brownsyne Tucker Edmonds, MD, MPH, MS — Indiana University
• Study coordinator: Shelley Hoffman, MPH

Conditions: Pregnancy Preterm, Premature Birth, Pregnancy Complications, Obstetric Labor, Premature, Obstetric Labor Complications, Decision making, Periviable delivery, Preterm birth