A decision support tool for families facing preterm delivery decisions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Brownsyne Tucker Edmonds, MD, MPH, MS — Indiana University
• Study coordinator: Shelley Hoffman, MPH
• Email: laymans@iu.edu
• Phone: 3172789636

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.