NCT04267211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

February 10, 2020

Last Update Submit

June 20, 2023

Conditions

Premature BirthPrenatal Stress

Outcome Measures

Primary Outcomes (1)

  • Maternal Anxiety

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

    Within 48 hours of consultation

Study Arms (2)

Illustrated Consult

EXPERIMENTAL
Other: Illustrated handout at prenatal consult

Standard Consult

EXPERIMENTAL
Other: Standard Prenatal Consult

Interventions

Illustrated handout at prenatal consultOTHER

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

Illustrated Consult
Standard Prenatal ConsultOTHER

Standard prenatal consult

Standard Consult

Eligibility Criteria

Age15 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women admitted to OB unit at the University of Virginia Medical Center
  • Estimated gestational age of \>25 weeks and \<35 weeks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UVA Health

Charlottesville, Virginia, 22908, United States

Location

Related 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.

    PMID: 32514007BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Namrita Odackal, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 12, 2020

Study Start

June 5, 2017

Primary Completion

June 4, 2019

Study Completion

June 4, 2019

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

US(1)