Improving Patient Understanding of Macrosomia
July 30, 2024 updated by: Kristen Cagino, The University of Texas Health Science Center, Houston
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
222
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: no additional information
|
Survey will be administered without reviewing the single sided card
|
|
Experimental: 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 as assessed by the score on a survey
Time Frame: immediately after intervention (about 5 minutes after intervention)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kristen Cagino, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2024
Primary Completion (Actual)
July 6, 2024
Study Completion (Actual)
July 6, 2024
Study Registration Dates
First Submitted
February 20, 2024
First Submitted That Met QC Criteria
February 20, 2024
First Posted (Actual)
February 28, 2024
Study Record Updates
Last Update Posted (Actual)
August 1, 2024
Last Update Submitted That Met QC Criteria
July 30, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.