The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth, Pregnancy Complications
About this trial
This is an interventional health services research trial for Pregnancy Preterm focused on measuring Decision making, Periviable delivery, Preterm birth, Risk Communication, Neonatal Resuscitation
Eligibility Criteria
Inclusion Criteria for Pregnant Persons:
- Adults (18 years or older)
- 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).
- 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)
Sites / Locations
- The University of California San Diego
- University of California San FranciscoRecruiting
- Indiana UniversityRecruiting
- The University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Usual Care (control)
Periviable GOALS DST Group
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.
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.