Prenatal Consult With Illustrated Literature

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Prenatal Stress Urogenital Diseases

Age range

15 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UVA Health

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Illustrated handout at prenatal consult

Other

Illustrated consult group will be given an illustration paper describing the majority of the issues discussed at the prenatal consult

Standard Prenatal Consult

Other

Standard prenatal consult

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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Acronym: PNCIL

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Feb 12, 2020
Registry last updated: Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed