Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

Study Overview
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Brief Summary
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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.

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

Conditions
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Premature Birth

Intervention / Treatment
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* Other: Written information and verbal counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>The control group will receive standard verbal counseling regarding outcome of premature infants | Other: Written information and verbal counseling<br>* control group will only receive verbal counseling. Study group will receive written information before verbal counseling<br>|
| Experimental: Study Group<br>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<br>* control group will only receive verbal counseling. Study group will receive written information before verbal counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prematurity Counseling for pregnant women and their family