Evaluating Decisional Regret Among Mothers

Delivery Decisions in Extreme Prematurity: Evaluating Decisional Regret

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04074525

Enrollment

211

Registered

2019-08-30

Start date

2020-03-24

Completion date

2021-06-30

Last updated

2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth, Preterm, Extreme Prematurity, Pregnancy Preterm

Keywords

Decisional regret, Comfort care, Palliative care, Infant resuscitation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results