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Periviable GOALS DST for Premature Birth

N/A

Recruiting

Led By Brownsyne Tucker Edmonds, MD, MPH, MS

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant between 22 0/7 to 24 6/7 weeks gestation

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

Awards & highlights

Study Summary

This trial is testing the effect of the Periviable GOALS decision support tool on shared decision making and decision satisfaction for families facing the threat of a periviable delivery.

Who is the study for?

This trial is for adults over 18 who are pregnant between 22 and almost 25 weeks, facing complications that could lead to very early delivery. They should have already discussed neonatal treatment options with their healthcare team and be able to make decisions for the baby.Check my eligibility

What is being tested?

The trial tests a decision support tool called Periviable GOALS DST designed to help parents make informed choices about neonatal resuscitation in extremely premature births. It aims to improve shared decision-making and satisfaction with the decisions made.See study design

What are the potential side effects?

Since this intervention is a decision support tool rather than a medical treatment, it does not have physical side effects. However, its impact on emotional or psychological well-being isn't detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 24 weeks pregnant.

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I am pregnant with complications that might lead to an early delivery.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

This trial's timeline: 3 weeks for screening, Varies for treatment, and before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Shared Decision Making

Secondary outcome measures

Acceptability of the decision support tool

Anxiety

Decision Control

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Periviable GOALS DST GroupExperimental Treatment1 Intervention

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.

Group II: Usual Care (control)Active Control1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,766 Total Patients Enrolled

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,822,132 Total Patients Enrolled

Brownsyne Tucker Edmonds, MD, MPH, MSPrincipal InvestigatorIndiana University School of Medicine

Media Library

Periviable GOALS DST Clinical Trial Eligibility Overview. Trial Name: NCT05264779 — N/A

Preterm Birth Research Study Groups: Usual Care (control), Periviable GOALS DST Group

Preterm Birth Clinical Trial 2023: Periviable GOALS DST Highlights & Side Effects. Trial Name: NCT05264779 — N/A

Periviable GOALS DST 2023 Treatment Timeline for Medical Study. Trial Name: NCT05264779 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the recruitment rate for this clinical trial?

"Yes, according to clinicaltrials.gov this medical trial is still seeking enrolment. It was first posted on May 6th 2022 and the most recent update occurred on May 25th of that same year. At present 216 people are being recruited at two distinct locations."

Answered by AI

Does this experiment have any open slots for new participants?

"Affirmative. The data hosted on clinicaltrials.gov states that this study, which was initially published on May 6th 2022, is still looking for participants. Two medical sites need to recruit a total of 216 patients for the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Periviable GOALS Decision Support Tool

Brownsyne Tucker Edmonds 2022. "The Periviable GOALS Decision Support Tool". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05264779.