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Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written information and verbal counseling
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth focused on measuring Prematurity Counseling for pregnant women and their family

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • English speaking pregnant women who are between 23-34 weeks of gestation
  • Who are 18 years and older
  • Open to all ethnic groups.
  • Admitted in preterm labor to Froedtert and Waukesha Hospitals labor and delivery unit.

Exclusion Criteria:

  • Pregnant women who are known to have infants with congenital anomalies or other associated conditions apart from prematurity that could be a significant factor to the outcome of the baby.
  • Pregnant women who have been included in this study and discharged at some point and again admitted for preterm labor will be excluded from the study.
  • If a participant delivers before completing the Parent Knowledge Questionnaire, she will be excluded.

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Study Group

Arm Description

The control group will receive standard verbal counseling regarding outcome of premature infants

Study Group will receive gestational age specific written information prior to receiving standard verbal counseling about outcome of premature infants.

Outcomes

Primary Outcome Measures

Maternal knowledge of problems of prematurity as measured by number of correct answers on the knowledge questionnaire will be assessed in the study and control groups.
The knowledge questionnaire consists of questions regarding gestational age specific common potential problems and complications of premature infants. We will score each questionniare and then compare number of correct answers.

Secondary Outcome Measures

The change in maternal anxiety score before and after counseling as measured by the State-Trait-Anxiety-Inventory will be compared between the study and control groups
State Trait anxiety Inventory has been used in many studies

Full Information

First Posted
July 26, 2010
Last Updated
December 16, 2013
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT01418950
Brief Title
Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information
Official Title
Improving Parental Knowledge: Randomized Trial of Supplementation of Prematurity Counseling With Written Information
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pregnant women who receive study counseling which includes gestational age specific written information in addition to the verbal counseling will have better knowledge of problems and outcomes of prematurity than women who receive standard counseling which consists of only verbal counseling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Prematurity Counseling for pregnant women and their family

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group will receive standard verbal counseling regarding outcome of premature infants
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Study Group will receive gestational age specific written information prior to receiving standard verbal counseling about outcome of premature infants.
Intervention Type
Other
Intervention Name(s)
Written information and verbal counseling
Intervention Description
control group will only receive verbal counseling. Study group will receive written information before verbal counseling
Primary Outcome Measure Information:
Title
Maternal knowledge of problems of prematurity as measured by number of correct answers on the knowledge questionnaire will be assessed in the study and control groups.
Description
The knowledge questionnaire consists of questions regarding gestational age specific common potential problems and complications of premature infants. We will score each questionniare and then compare number of correct answers.
Time Frame
Within 24 hours of counseling the primary outcome will be assessed
Secondary Outcome Measure Information:
Title
The change in maternal anxiety score before and after counseling as measured by the State-Trait-Anxiety-Inventory will be compared between the study and control groups
Description
State Trait anxiety Inventory has been used in many studies
Time Frame
The pre-counseling anxiety score will be obtained immediately after consent is obtained for the study. The post-counseling anxiety score will be obtained within 24 hours of counseling

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English speaking pregnant women who are between 23-34 weeks of gestation Who are 18 years and older Open to all ethnic groups. Admitted in preterm labor to Froedtert and Waukesha Hospitals labor and delivery unit. Exclusion Criteria: Pregnant women who are known to have infants with congenital anomalies or other associated conditions apart from prematurity that could be a significant factor to the outcome of the baby. Pregnant women who have been included in this study and discharged at some point and again admitted for preterm labor will be excluded from the study. If a participant delivers before completing the Parent Knowledge Questionnaire, she will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir Basir, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22492766
Citation
Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.
Results Reference
derived

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Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

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