Status:
RECRUITING
The Periviable GOALS Decision Support Tool
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Agency for Healthcare Research and Quality (AHRQ)
Conditions:
Pregnancy Preterm
Premature Birth
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 fa...
Detailed Description
The investigators will evaluate the Periviable GOALS DST in a randomized controlled trial among 144 pregnant patients between 22 0/7 and 25 6/7 weeks gestation who are hospitalized for a pregnancy com...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05264779
Start Date
June 6 2022
End Date
February 1 2027
Last Update
October 10 2025
Active Locations (10)
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1
The University of California San Diego
San Diego, California, United States, 92121
2
University of California San Francisco
San Francisco, California, United States, 94143
3
Yale University
New Haven, Connecticut, United States, 06510
4
Northwestern University
Chicago, Illinois, United States, 60611