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Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01418950
First received: July 26, 2010
Last updated: August 16, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Premature Birth
 Other: Written information and verbal counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Parental Knowledge: Randomized Trial of Supplementation of Prematurity Counseling With Written Information

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

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. [ Time Frame: Within 24 hours of counseling the primary outcome will be assessed ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    State Trait anxiety Inventory has been used in many studies


Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group
The control group will receive standard verbal counseling regarding outcome of premature infants
 Other: Written information and verbal counseling
control group will only receive verbal counseling. Study group will receive written information before verbal counseling
Experimental: Study Group
Study Group will receive gestational age specific written information prior to receiving standard verbal counseling about outcome of premature infants.
 Other: Written information and verbal counseling
control group will only receive verbal counseling. Study group will receive written information before verbal counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418950

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Mir Basir, MD Medical College of Wisconsin
  More Information

No publications provided by Medical College of Wisconsin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mir Basir, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01418950     History of Changes
Other Study ID Numbers: PRO00010267
Study First Received: July 26, 2010
Last Updated: August 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Prematurity Counseling for pregnant women and their family

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

ClinicalTrials.gov processed this record on May 21, 2013