Prenatal Consult With Illustrated Literature

NCT ID: NCT04267211

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2019-06-04

Brief Summary

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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

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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.

Conditions

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Premature Birth Prenatal Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Illustrated Consult

Group Type EXPERIMENTAL

Illustrated handout at prenatal consult

Intervention Type OTHER

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

Standard Consult

Group Type EXPERIMENTAL

Standard Prenatal Consult

Intervention Type OTHER

Standard prenatal consult

Interventions

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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

Intervention Type OTHER

Standard Prenatal Consult

Standard prenatal consult

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Swanson, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Namrita Odackal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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UVA Health

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32514007 (View on PubMed)

Other Identifiers

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19892

Identifier Type: -

Identifier Source: org_study_id

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