Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

Premature Birth Clinical Trial

Official title:

Improving Parental Knowledge: Randomized Trial of Supplementation of Prematurity Counseling With Written Information

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418950
• Other study ID #: PRO00010267
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: December 16, 2013
• Start date: April 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2013
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• Written information and verbal counseling
control group will only receive verbal counseling. Study group will receive written information before verbal counseling

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 24 hours of counseling the primary outcome will be assessed	No
Secondary	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	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	No