Evaluating Decisional Regret Among Mothers

Delivery Decisions in Extreme Prematurity: Evaluating Decisional Regret

The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. Failure to identify and align decision-making to parents' values during periviabilty counseling may result in greater opportunity for decisional regret. The goal of the proposed research is to assess decisional regret in mothers of extremely premature births and to compare decisional regret in mothers who chose resuscitation at time of delivery to those who chose comfort care. Approximately 1000 mothers of infants born extremely premature at 2 perinatal centers in the US will be surveyed.

Study Overview

• Status: Completed
• Conditions: Pregnancy Preterm; Birth, Preterm; Extreme Prematurity

• Study Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of mothers who delivered infants between 22 and 25 completed weeks gestation during the study timeframe at one of two US perinatal centers.

Description

Inclusion Criteria:

• Mothers of infants born between 22 and 25 completed weeks gestation during the study timeframe.
• Mothers who had a documented perinatal consult
• Greater than 18 years old

Exclusion Criteria:

• Potential life limiting fetal diagnoses aside from prematurity and non-English primary language

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional regret	To assess decisional regret in mothers of extremely premature liveborn infants.	Within the last 14 years
Comparison of decisional regret	Comparison of decisional regret in mothers who chose resuscitation versus mothers who chose comfort care at the time of delivery.	Within the last 14 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Define characteristics associated with decisional regret	Identify characteristics, and specifically potentially modifiable characteristics, that are associated with decisional regret in our population of mothers.	Within the last 14 years

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Collaborators: Providence Health & Services
• Investigators: Principal Investigator: Laura Belden, DO, Christiana Care Health Services, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Palliative care; Decisional regret; Comfort care; Infant resuscitation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: DDD604440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No