Improving Patient Understanding of Macrosomia

Macrosomia, Fetal Clinical Trial

Official title:

Improving Patient Understanding of Macrosomia: a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281301
• Other study ID #: HSC-MS-23-1023
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Kristen Cagino, MD
• Phone: (713) 500-6412
• Email: Kristen.A.Cagino[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: September 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• singleton pregnancy

• greater than or equal to 36 weeks gestation.

Exclusion Criteria:

• unable to provide informed consent

Related Conditions & MeSH terms

• Fetal Macrosomia
• Macrosomia, Fetal

Intervention

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.
• no additional information
Survey will be administered without reviewing the single sided card

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)