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Clinical Trials/NCT04074525
NCT04074525
Completed
Not Applicable

Delivery Decisions in Extreme Prematurity: Evaluating Decisional Regret

Christiana Care Health Services1 site in 1 country211 target enrollmentMarch 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Extreme Prematurity
Sponsor
Christiana Care Health Services
Enrollment
211
Locations
1
Primary Endpoint
Comparison of decisional regret
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 24, 2020
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Comparison of decisional regret

Time Frame: 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

Time Frame: Within the last 14 years

To assess decisional regret in mothers of extremely premature liveborn infants.

Secondary Outcomes

  • Define characteristics associated with decisional regret(Within the last 14 years)

Study Sites (1)

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