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OpenTrials
Completed

NCT Number: NCT04074525

Evaluating Decisional Regret Among Mothers

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.

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Key information

Conditions

Extreme Prematurity Birth, Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Pregnancy Preterm Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Decisional regret

    Time frame: Within the last 14 years

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

  2. 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.

Secondary outcomes

  1. Define characteristics associated with decisional regret

    Time frame: Within the last 14 years

    Identify characteristics, and specifically potentially modifiable characteristics, that are associated with decisional regret in our population of mothers.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • Providence Health & Services

Registry information

Official study title

Delivery Decisions in Extreme Prematurity: Evaluating Decisional Regret

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 30, 2019
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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