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Clinical Trials/NCT04267211
NCT04267211
Completed
Not Applicable

Prenatal Consult With Illustrated Literature

University of Virginia1 site in 1 country82 target enrollmentJune 5, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
University of Virginia
Enrollment
82
Locations
1
Primary Endpoint
Maternal Anxiety
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The overall purpose of this study is to determine whether implementing a 'Prenatal Consult Bundle' to the existing prenatal consult, including provision of sample questions, added discussion points and handouts, and a return visit, will decrease parental anxiety and improve information recall. Additionally, this study will determine if this effect is further increased with the use of illustrated literature.

Detailed Description

This study will be a prospective randomized control trial. Seventy participants will be enrolled for the 'Standard' consult. These women will receive a questionnaire 6-24 hours after their consult. Then 140 participants will be randomized to either the 'Standard Upgrade' or 'Illustrated Upgrade' arm. Randomization will additionally be stratified based on estimated gestational age. These participants will receive an upgraded consult implementing the 'Prenatal Consult Bundle' which emphasizes the parents' role and follow up, with or without an illustrated handout. These participants will receive the same questionnaire 6-24 hours after their consult. Demographic information collected will include maternal age, gravidity, use of magnesium, social support and health literacy. All data will be collected to assess whether either arm of the consult 'upgrade' reduces anxiety or improves knowledge retention after the prenatal consult. Analyses will be completed using Statistical Analysis Software (SAS) using appropriate statistical testing.

Registry
clinicaltrials.gov
Start Date
June 5, 2017
End Date
June 4, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan Swanson, MD

Associate Professor

University of Virginia

Eligibility Criteria

Inclusion Criteria

  • Pregnant women admitted to OB unit at the University of Virginia Medical Center
  • Estimated gestational age of \>25 weeks and \<35 weeks

Exclusion Criteria

  • Non-English Speaking
  • Pregnant women \<15 years of age
  • Known critical conditions or congenital anomalies
  • Women who have had any prior prenatal consultations regarding current pregnancy

Outcomes

Primary Outcomes

Maternal Anxiety

Time Frame: Within 48 hours of consultation

Using the State-Trait Anxiety Inventory (STAI), maternal anxiety will be assessed between the two groups

Study Sites (1)

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