Improving Patient Understanding of Macrosomia

Improving Patient Understanding of Macrosomia: a Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Macrosomia, Fetal
• Intervention / Treatment: Other: no additional information; Other: education tool

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen Cagino, MD; Phone Number: (713) 500-6412; Email: Kristen.A.Cagino@uth.tmc.edu
• Study Contact Backup: Name: Suneet Chauhan; Email: mfmchauhan@gmail.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Kristen Cagino, MD; Phone Number: 713-500-6412; Email: Kristen.A.Cagino@uth.tmc.edu
      • Contact: Suneet Chauhan; Email: mfmchauhan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: no additional information	Other: no additional information; Survey will be administered without reviewing the single sided card
Experimental: education tool	Other: education tool; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that showed Macrosomia knowledge greater than 50 percent as assessed by the score on a survey	This survey has 18 questions and will be scored from 1-18 higher number indicating better outcome	immediately after intervention (about 5 minutes after intervention)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Kristen Cagino, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Body Weight; Fetal Diseases; Pregnancy Complications; Diabetes, Gestational; Pregnancy in Diabetics; Birth Weight; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Macrosomia
• Other Study ID Numbers: HSC-MS-23-1023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No