Evaluating Decisional Regret Among Mothers

Extreme Prematurity Clinical Trial

Official title:

Delivery Decisions in Extreme Prematurity: Evaluating Decisional Regret

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074525
• Other study ID #: DDD604440
• Status: Completed
• Start date: March 24, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Birth, Preterm
• Extreme Prematurity
• Pregnancy Preterm
• Premature Birth

Locations

Country	Name	City	State
United States	Christiana Care Health Services, Inc.	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional regret	To assess decisional regret in mothers of extremely premature liveborn infants.	Within the last 14 years
Primary	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	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