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Clinical Trials/NCT01418950
NCT01418950CompletedNot Applicable

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

Medical College of Wisconsin2 sites in 1 country60 target enrollmentStarted: April 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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