The Periviable GOALS Decision Support Tool for Premature Birth

This study is testing an iPad application called the Periviable GOALS Decision Support Tool (DST). This tool helps families understand complex medical information and clarify their values when facing the possibility of a very premature birth (between 22 and 25 weeks of pregnancy). It uses graphics and videos and is designed for parents to review on their own, to help them make informed decisions about care for their baby. Researchers want to see if using this tool improves shared decision-making and how satisfied parents are with their decisions after delivery. You might be able to join if you are at least 18 years old, pregnant between 22 and 25 weeks, and have a pregnancy complication that could lead to an early delivery. The study aims to enroll 300 participants, but the current recruitment status is unclear.

Study design: This is a randomized controlled trial involving 144 pregnant patients and 72 'important others' (like partners or family members). Participants will be assigned by chance to either use the Periviable GOALS DST or not.
What's involved: You would participate in 3-4 data collection points, depending on which group you are in. You would also identify an 'important other' to be included in the study.
Compensation: Not stated in the trial record.
Follow-up: Your shared decision-making and decision satisfaction will be measured between 1 day and 2 weeks after delivery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

The Periviable GOALS Decision Support Tool

Recruiting

NAAges 18+InterventionalHealth services

Indiana University

~300 participants

Updated 2026-05-11 on ClinicalTrials.gov

What's tested:Periviable GOALS DST

At a glance

Recruiting sites

11 of 12 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Shared Decision Making

Measured over 1 day to 2 weeks after delivery

+1 more outcome measured

Conditions

Pregnancy Preterm

Premature Birth

Pregnancy Complications

Obstetric Labor, Premature

Obstetric Labor Complications

Where it's being run

12 sites across 11 states

California2

Connecticut1

Illinois1

Indiana1

Kansas1

Kentucky1

Massachusetts1

Ohio1

Study leadership

Brownsyne Tucker Edmonds, MD, MPH, MS · PRINCIPAL_INVESTIGATOR · Indiana University
Miriam Kuppermann, PhD, MPH · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Shelley Hoffman, MPH

[email protected]

3172789636

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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.

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

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)

What this trial measures

Shared Decision Making1 day to 2 weeks after delivery
9-item Shared Decision Making Questionnaire (SDM-Q-9) administered in-person or via phone/Zoom call. Scores range from 0 to 100, with a higher score correlating to higher shared decision making.
Decision Satisfaction1 day to 2 weeks after delivery
6-item Satisfaction with Decision Scale, administered in-person or via phone/Zoom call at three time points. There are 5 response categories ranging from 1 (strongly disagree) to 5 (strongly agree) with higher scores correlating to higher decision satisfaction.

Trialytics