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Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01418950
Enrollment
60
Registered
2011-08-17
Start date
2009-04-30
Completion date
2012-03-31
Last updated
2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Prematurity Counseling for pregnant women and their family

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.

Interventions

OTHERWritten information and verbal counseling

control group will only receive verbal counseling. Study group will receive written information before verbal counseling

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
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 assessedThe 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

MeasureTime frameDescription
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 groupsThe 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 counselingState Trait anxiety Inventory has been used in many studies

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026