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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Premature Birth
• Prenatal Stress

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