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Periviable GOALS DST for Preterm Birth

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California San Francisco, San Francisco, CAPreterm Birth+4 MorePeriviable GOALS DST - Other
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Preterm Birth
  • Premature Labor
  • Premature Birth
  • Pregnancy Complications
  • Obstetric Labor Complications

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Mutual Goal-Setting Education
1
Usual Care
1
Shared Decision Aid Assessment

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

Week 2
Shared Decision Making
Month 6
Decision Control
Decision Regret
Decisional Conflict
Month 6
Decision Satisfaction
Before delivery
Acceptability of the decision support tool
Knowledge about Periviable Delivery
Preparation for Decision Making
Day 2
Resuscitation procedure
Month 6
Anxiety
Depression
Post-Traumatic Stress Disorder
Month 6
Neonatal Outcome
Neonatal Treatment Provided

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Mutual Goal-Setting Education
1
Usual Care
1
Shared Decision Aid Assessment

Trial Design

2 Treatment Groups

Usual Care (control)
1 of 2
Periviable GOALS DST Group
1 of 2

Active Control

Experimental Treatment

216 Total Participants · 2 Treatment Groups

Primary Treatment: Periviable GOALS DST · No Placebo Group · N/A

Periviable GOALS DST Group
Other
Experimental Group · 1 Intervention: Periviable GOALS DST · Intervention Types: Other
Usual Care (control)NoIntervention Group · 1 Intervention: Usual Care (control) · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: before delivery, up to 2 weeks postpartum, 3 months postpartum, and 6 months postpartum.

Who is running the clinical trial?

Indiana UniversityLead Sponsor
893 Previous Clinical Trials
766,491 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
366 Previous Clinical Trials
6,940,310 Total Patients Enrolled
Miriam Kuppermann, PhD, MPHPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
3,407 Total Patients Enrolled
Brownsyne Tucker Edmonds, MD, MPH, MSPrincipal InvestigatorIndiana University School of Medicine

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be 18 years old or older.
You are in the middle stages of pregnancy, around 5-6 months along.
You are pregnant and experiencing complications that may require delivering the baby earlier than expected.
Your healthcare team has talked to you about the different options for treating your newborn, such as resuscitation or comfort care, before the study team talks to you.
Only one person who is pregnant is allowed to participate.
You are someone who will help make decisions for the baby.
You must be available and willing to participate at the time of selection.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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