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NCT04267211 Clinical Trial

Prenatal Consult With Illustrated Literature

Premature Birth Clinical Trial

— PNCIL  

Official title:
Prenatal Consult With Illustrated Literature

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04267211
Other study ID # 19892
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2017
Est. completion date June 4, 2019

Study information
Verified date June 2023
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date June 4, 2019
Est. primary completion date June 4, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Illustrated handout at prenatal consult
Illustrated consult group will be given an illustration paper describing the majority of the issues discussed at the prenatal consult
• Standard Prenatal Consult
Standard prenatal consult

Locations
Country Name City State
United States UVA Health Charlottesville Virginia

Sponsors (1)
Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Odackal NJ, Conaway M, Cha J, Swanson JR. Prenatal consults with illustrated literature (PnCIL): a RCT studying visual aids during prenatal consults. J Perinatol. 2020 Aug;40(8):1154-1162. doi: 10.1038/s41372-020-0709-y. Epub 2020 Jun 8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Maternal Anxiety Using the State-Trait Anxiety Inventory (STAI), maternal anxiety will be assessed between the two groups Within 48 hours of consultation
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