Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT05264779

Conditions

Pregnancy Preterm

Premature Birth

Pregnancy Complications

Obstetric Labor, Premature

Obstetric Labor Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Periviable GOALS DST

Study Details

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 facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.

Conditions

Pregnancy Preterm

Premature Birth

Pregnancy Complications

Obstetric Labor, Premature

Obstetric Labor Complications

Study ID

NCT05264779

Start date

Jun 6, 2022

Status verified date

Apr, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual Care (control)

Participants assigned to this group will proceed with usual medical care and treatment, consisting of counseling by the teams of obstetricians and/or neonatologists at the respective study sites.

experimental: Periviable GOALS DST Group

Participants randomized to the intervention will be presented with the Periviable GOALS DST and instructed to review the DST in its entirety. The participant will complete the education and values clarification components of the DST with the Recruitment RA present to confirm completion. Following completion of the GOALS DST, the Recruitment RA will repeat knowledge and decisional conflict instruments and assess acceptability.

Interventions

Periviable GOALS DST

An iPad application that contains outcomes information, values clarification and embedded short documentary style videos. The tool was designed with low-literacy and low-numeracy populations in mind, and utilizes graphics and video content to enhance meaning-making of complex medical information and jargon. The GOALS DST refers patients back to their physicians to discuss specific treatment options, local outcomes, and management strategies available to them. The DST's content focuses largely on helping patients better understand the choice they have between comfort care and life-sustaining efforts in the context of periviable delivery.

Primary outcome measure

  • Shared Decision Making [ Time Frame: 1 day to 2 weeks after delivery ]
  • Decision Satisfaction [ Time Frame: 1 day to 2 weeks after delivery ]

Central Contacts and Locations

Central contacts

Shelley Hoffman, MPH

3172789636laymans@iu.edu

Locations

The University of California San Diego

Recruiting

San Diego, California, United States, 92121

Contacts

Samantha LaBelle

slabelle@health.ucsd.edu

Principal Investigator:

Cynthia Gyamfi-Bannerma, MD, MS

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Kimberly Coleman-Phox, MPH

(415) 476-6406Kimberly.Coleman-Phox@ucsf.edu

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Lauren Perley

lauren.perley@yale.edu

Principal Investigator:

Mert Bahtiyar, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Brittney M Williams, MPH

3125033476brittney.williams@northwestern.edu

Principal Investigator:

Lynn M Yee, MD, MPH

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Shelley M Hoffman, MPH

3172789636laymans@iu.edu

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Raysa Williams

913-588-5000swilliams14@kumc.edu

Principal Investigator:

Megan M Thomas, MD

The University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Shawn England, MA, CCRP

8596089393shawn.england@uky.edu

Principal Investigator:

Emily DeFranco, DO, MS

University of Massachusetts

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Monalisa Dmello

Monalisa.Dmello@umassmemorial.org

Principal Investigator:

Katherine M Johnson, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Anna Bartholomew, MPH, RN

6146853229mailto:anna.bartholomew@osumc.edu

Principal Investigator:

William Grobman, MD, MBA

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Meaghan McCabe, MPH

9737472824meaghan.mccabe@pennmedicine.upenn.edu

Principal Investigator:

Sindhu K Srinivas, MD, MSCE

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Brooke Lasher

5123247036brooke.lasher@austin.utexas.edu

Principal Investigator:

Lorie Harper, MD, MSCI

More Information

Sponsor

Indiana University

Last update posted

May 11, 2026

Last verified

Apr, 2026

Keywords

  • Decision making
  • Periviable delivery
  • Preterm birth
  • Risk Communication
  • Neonatal Resuscitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-11.