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Decision Aid - Extreme Prematurity

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ClinicalTrials.gov Identifier: NCT01713894
Recruitment Status : Recruiting
First Posted : October 25, 2012
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Prematurity; Decision Support Other: Decision Aid Other: Standard

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery
Study Start Date : May 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Knowledge [ Time Frame: within 1 week after consult ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713894

Contact: Ursula Guillen, MD 302-733-2410 uguillen@christianacare.org
Contact: Amy Mackley, MSN 302-733-2153 amackley@christianacare.org

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
ClinicalTrials.gov Identifier: NCT01713894     History of Changes
Other Study ID Numbers: Decision Aid - Prematurity
First Posted: October 25, 2012    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by Ursula Guillen, Christiana Care Health Services:
Limits of viability

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications