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Decision Aid - Extreme Prematurity

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Christiana Care Health Services
Virtua Health
University of Michigan
NorthShore University HealthSystem Research Institute
Information provided by (Responsible Party):
Ursula Guillen, Christiana Care Health Services Identifier:
First received: October 22, 2012
Last updated: August 23, 2016
Last verified: August 2016
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?

Condition Intervention
Prematurity; Decision Support
Other: Decision Aid
Other: Standard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Decisional conflict [ Time Frame: within 1 week after consult ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Knowledge [ Time Frame: within 1 week after consult ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Decision Aid
In this arm of the study, parents will be counseled using a decision aid.
Other: Decision Aid
In this arm of the study, parents will be counseled using current standard methods.
Other: Standard


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01713894

Contact: Ursula Guillen, MD 302-733-2410
Contact: Amy Mackley, MSN 302-733-2153

United States, Delaware
Christiana Care Health System Recruiting
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Christiana Care Health Services
Virtua Health
University of Michigan
NorthShore University HealthSystem Research Institute
Principal Investigator: Ursula Guillen, MD Christiana Care Health Systems
  More Information

Responsible Party: Ursula Guillen, Principal Investigator; Assistant Professor, Christiana Care Health Services Identifier: NCT01713894     History of Changes
Other Study ID Numbers: Decision Aid - Prematurity 
Study First Received: October 22, 2012
Last Updated: August 23, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Limits of viability

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on October 25, 2016