Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Other: Written information and verbal counseling

• Registration Number: NCT01418950
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Written information and verbal counseling	The control group will receive standard verbal counseling regarding outcome of premature infants
Study Group	Written information and verbal counseling	Study Group will receive gestational age specific written information prior to receiving standard verbal counseling about outcome of premature infants.

Primary Outcome Measures

Name	Time	Method
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.	Within 24 hours of counseling the primary outcome will be assessed	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

Name	Time	Method
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	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	State Trait anxiety Inventory has been used in many studies

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States