Evaluating Decisional Regret Among Mothers

NCT ID: NCT04074525

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

211 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-24

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Extreme Prematurity Birth, Preterm Pregnancy Preterm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Providence Health & Services

OTHER

Sponsor Role collaborator

Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Belden, DO

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services, Inc.

Locations

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Christiana Care Health Services, Inc.

Newark, Delaware, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39164062 (View on PubMed)

Other Identifiers

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DDD604440

Identifier Type: -

Identifier Source: org_study_id

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