Evaluating Decisional Regret Among Mothers

Completed

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

• Registration Number: NCT04074525
• Lead Sponsor: Christiana Care Health Services

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Study Start: 2020-03-24
• Primary Completion: 2021-05-30
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 211

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Christiana Care Health Services, Inc.; 🇺🇸 Newark, Delaware, United States