Macrosomia, FetalNCT06281301
Improving Patient Understanding of Macrosomia
A study testing education tool and no additional information in people with Macrosomia, Fetal, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Macrosomia, Fetal
- What is being tested?
- education tool and no additional information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to 6 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton pregnancy
- greater than or equal to 36 weeks gestation.
Who cannot join
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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.
- Conditions
- Macrosomia, Fetal
- Being tested
- education tool, no additional information
- Medical subject headings
- Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
no additional informationOther
Survey will be administered without reviewing the single sided card
| Study group | Role | What they receive |
|---|---|---|
| no additional information | Other | Not described Receives: Other: no additional information |
| education tool | Experimental | Not described Receives: Other: education tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately after intervention (about 5 minutes after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start30 Jan 2024
- Primary completion6 Jul 2024
- Study completion6 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macrosomia, FetalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Cagino, The University of Texas Health Science Center, Houston
- Investigators
- Kristen Cagino, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281301
- Sponsor's protocol ID
- HSC-MS-23-1023
- Status last verified
- Jul 2024
- First submitted
- 20 Feb 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Understanding of Macrosomia: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06281301
- Acronym / sponsor ID
- HSC-MS-23-1023
- Conditions
- Macrosomia, Fetal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 6 Jul 2024 (actual)
- Study completion
- 6 Jul 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no additional information | Other | Other: no additional information |
| education tool | Experimental | Other: education tool |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- singleton pregnancy
- greater than or equal to 36 weeks gestation.
Key exclusion criteria (1 listed)
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education toolParticipants 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. | Other | education tool |
| no additional informationSurvey will be administered without reviewing the single sided card | Other | no additional information |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Cagino, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education tool and no additional information in people with Macrosomia, Fetal, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.