Evaluating Decisional Regret Among Mothers

NCT04074525 | Completed

• 1 other identifier: DDD604440
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Extreme Prematurity; Birth, Preterm; Pregnancy Preterm

Keywords

Decisional regret; Comfort care; Palliative care; Infant resuscitation

Outcome Measures

Primary Outcomes (2)

• Decisional regret

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

  Within the last 14 years

• 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 Outcomes (1)

• Define characteristics associated with decisional regret

  Within the last 14 years

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender eligibility for this study will be determined by women who had the ability to become pregnant and give birth at one of 2 perinatal centers.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of mothers who delivered infants between 22 and 25 completed weeks gestation during the study timeframe at one of two US perinatal centers.

You may qualify if:

• 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

You may not qualify if:

• Potential life limiting fetal diagnoses aside from prematurity and non-English primary language

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Providence Health & Services: collaborator

Study Sites (1)

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Location

Related Publications (1)

• Belden L, Kaempf J, Mackley A, Kernan-Schloss F, Chen C, Sturtz W, Tomlinson MW, Guillen U. Evaluating decision regret after extremely preterm birth. Arch Dis Child Fetal Neonatal Ed. 2025 Feb 21;110(2):191-199. doi: 10.1136/archdischild-2024-327287.

  PMID: 39164062 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Laura Belden, DO

  Christiana Care Health Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: March 24, 2020
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)