Prenatal Consult With Illustrated Literature

Not Applicable

Completed

• Conditions: Prenatal Stress; Premature Birth
• Interventions: Other: Standard Prenatal Consult; Other: Illustrated handout at prenatal consult

• Registration Number: NCT04267211
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2017-06-05
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-04
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Consult	Standard Prenatal Consult	-
Illustrated Consult	Illustrated handout at prenatal consult	-

Primary Outcome Measures

Name	Time	Method
Maternal Anxiety	Within 48 hours of consultation	Using the State-Trait Anxiety Inventory (STAI), maternal anxiety will be assessed between the two groups

Trial Locations

Locations (1)

UVA Health; 🇺🇸 Charlottesville, Virginia, United States