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Prenatal Consult With Illustrated Literature (PNCIL)

Primary Purpose

Premature Birth, Prenatal Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Illustrated handout at prenatal consult
Standard Prenatal Consult
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Birth

Eligibility Criteria

15 Years - 99 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UVA Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Illustrated Consult

Standard Consult

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 10, 2020
Last Updated
June 20, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04267211
Brief Title
Prenatal Consult With Illustrated Literature
Acronym
PNCIL
Official Title
Prenatal Consult With Illustrated Literature
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
June 4, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Prenatal Stress

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Illustrated Consult
Arm Type
Experimental
Arm Title
Standard Consult
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Illustrated handout at prenatal consult
Intervention Description
Illustrated consult group will be given an illustration paper describing the majority of the issues discussed at the prenatal consult
Intervention Type
Other
Intervention Name(s)
Standard Prenatal Consult
Intervention Description
Standard prenatal consult
Primary Outcome Measure Information:
Title
Maternal Anxiety
Description
Using the State-Trait Anxiety Inventory (STAI), maternal anxiety will be assessed between the two groups
Time Frame
Within 48 hours of consultation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Namrita Odackal, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA Health
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32514007
Citation
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.
Results Reference
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Prenatal Consult With Illustrated Literature

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