NCT06281301

Brief Summary

The purpose of this study is to evaluate the effectiveness of a graphic based education tool on patient knowledge of macrosomia through the use of a survey and to evaluate knowledge at 1-2 weeks after initial review of the education tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

February 20, 2024

Last Update Submit

July 30, 2024

Conditions

Macrosomia, Fetal

Outcome Measures

Primary Outcomes (1)

  • Number of participants that showed Macrosomia knowledge as assessed by the score on a survey

    This survey has 17 questions and will be scored from 1-17 higher number indicating better outcome

    immediately after intervention (about 5 minutes after intervention)

Study Arms (2)

no additional information

OTHER
Other: no additional information

education tool

EXPERIMENTAL
Other: education tool

Interventions

education toolOTHER

Participants will have 15 minutes to review the single sided card and then the survey will be administered. Participants will then be surveyed again within 1-2 weeks after initial completion to assess how well information was retained.

education tool
no additional informationOTHER

Survey will be administered without reviewing the single sided card

no additional information

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancy
  • greater than or equal to 36 weeks gestation.

You may not qualify if:

  • unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Fetal Macrosomia

Condition Hierarchy (Ancestors)

Diabetes, GestationalPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPregnancy in DiabeticsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBirth WeightBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kristen Cagino, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

February 20, 2024

First Posted

February 28, 2024

Study Start

January 30, 2024

Primary Completion

July 6, 2024

Study Completion

July 6, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)