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OpenTrials
Completed

NCT Number: NCT01713894

Decision Aid - Extreme Prematurity

The purpose of this study is to assess in a pilot randomized controlled trial the following PICOT question: In parents facing extreme premature delivery, does the use of an existing validated visual decision aid as compared to standard counseling, reduce the primary outcome of parental decisional conflict? Furthermore, is such a decision aid understood and applicable across differing populations of different ethnic backgrounds and social classes?

Completed

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Key information

Conditions

Prematurity; Decision Support Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health System

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • physicians who counsel women at the limits of viability
  • women who are receiving counseling at the limits of viability

Exclusion criteria

  • Known congenital malformations or lethal anomalies, still birth in which the fetuses' death was known before labor.

Treatment and study plan

Decision Aid

Other

standard

Other

Primary outcomes

  1. Decisional conflict

    Time frame: within 1 week after consult

    Decisional conflict is the state of uncertainty about the course of action to take when making choices involving risk or uncertainty of outcomes. Decisional conflict is assessed using the Decisional Conflict Scale

Secondary outcomes

  1. Knowledge

    Time frame: within 1 week after consult

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • Endeavor Health
  • University of Michigan
  • Virtua Health

Registry information

Official study title

Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2012
Registry last updated
Jan 12, 2018

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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