ObesityNCT04639973
Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O)
A study testing Group 1 (First trimester ultrasound) and Group 2 (Second trimester anatomy ultrasound) in people with Obesity, 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 assess the feasibility of ultrasound in the first trimester, assess the completion rate of ultrasounds for fetal anatomy in the first trimester compared to completion rates of ultrasounds for fetal anatomy in the second trimester and to assess the completion rate of the combination of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Group 1 (First trimester ultrasound) and Group 2 (Second trimester anatomy ultrasound)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 21 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI greater than or equal to 35
- Presented for ultrasound before 14 weeks at The University of Texas Professional Building, Memorial City, Bellaire, or Lyndon-Baines Johnson clinics
- Primary language is English or Spanish
- Consent to an extra transvaginal ultrasound if needed
- Singleton gestation
- No previous anomalies known before consent
- Missed abortion (nonviable pregnancy)
Who cannot join
- Elective abortion after recruitment
- Missed abortion after first trimester ultrasound
- Did not receive second trimester ultrasound
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: Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O): A Randomized Controlled Trial
The purpose of this study is to assess the feasibility of ultrasound in the first trimester, assess the completion rate of ultrasounds for fetal anatomy in the first trimester compared to completion rates of ultrasounds for fetal anatomy in the second trimester and to assess the completion rate of the combination of one ultrasound in the first trimester and one in the second trimesters compared to the individual completion rates of both evaluations in obese pregnant women.
- Conditions
- Obesity
- Being tested
- Group 1 (First trimester ultrasound), Group 2 (Second trimester anatomy ultrasound)
- Keywords
- pregnancy, fetal ultrasound
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 (First trimester ultrasound)Diagnostic test
A detailed first trimester anatomy ultrasound will be performed,at the visit when the subject is confirmed to be of eligible gestational age. After this detailed research ultrasound, which will be limited to 15 minutes, subject will then receive the clinically indicated dating ultrasound or nuchal translucency measurement. The patient will complete a survey about her satisfaction with this technique via email.as a safety measure, if an anomaly is suspected on the day of the detailed first trimester anatomy scan, the patient will be unblinded. Patients in this arm are later scheduled for a second trimester ultrasound by the clinical team, as this is part of standard obstetrical care.
Group 2 (Second trimester anatomy ultrasound)Diagnostic test
Patients do not undergo a detailed first trimester ultrasound , but will receive the clinically indicated limited ultrasound for dating or for nuchal translucency. Patient will then undergoes a second trimester ultrasound by the clinical team as part of standard obstetrical care and completes a survey regarding her satisfaction with this technique via email.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (First trimester ultrasound) | Experimental | Not described Receives: Diagnostic Test: Group 1 (First trimester ultrasound) |
| Group 2 (Second trimester anatomy ultrasound) | Active comparator | Not described Receives: Diagnostic Test: Group 2 (Second trimester anatomy ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate for First Trimester Scans
Completion rate is reported as the number of scans that see all the views divided by total number of scans in that group
Measured: 12-14 weeks of pregnancy
Completion Rate for Second Trimester Scans
Completion rate is reported as the number of scans that see all the views divided by total number of scans.
Measured: 18-22 weeks of pregnancy
Secondary outcomes (13)
Completion Rate of First Trimester and Second Trimester Scans
This outcome is reported as [(# of completed 1st tri anatomy scans) + (# of completed 2nd tri anatomy scans in women without a completed first tri anatomy scan)]/(total number of women in first trimester group).
Measured: 12-22 weeks of pregnancy
Time Taken to Complete Scan in the First Trimester Ultrasound Group
Measured: 12-14 weeks of pregnancy
Number of Anomalies Identified in First Trimester Group Scans
Measured: 12-14 weeks of pregnancy
Number of Anomalies Identified in Second Trimester Group Scans
Measured: 12-22 weeks of pregnancy
Number of Anomalies Missed in First Trimester Group Scans
Measured: 12-14 weeks of pregnancy
Number of Anomalies Missed in Second Trimester Group Scans
Measured: 12-22 weeks of pregnancy
Number of Participants With Infants Who Survive
Measured: 9 months from randomization
Gestational Age at Delivery
Measured: at the time of delivery (about 40 weeks of pregnancy)
Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU)
Measured: at the time of NICU admission (about 0 to 28 days after birth)
Hospital Length of Stay
Measured: from time of hospital admission to discharge (about 0 to 365 days after birth)
Number of Participants With Infants With Neonatal Morbidities
Neonatal morbidities include hypoglycemia
Measured: 9 months from randomization
Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans
The survey asks "Overall, how satisfied were you with today's ultrasound?," and participants selected one of the below choices. Number who chose "Very Satisfied" is reported.
- Very satisfied
- Somewhat satisfied
- Neither satisfied nor dissatisfied
- Somewhat dissatisfied
- Very dissatisfied
Measured: 6 months from randomization
Cost of Intervention Compared to Usual Care
cost benefit analysis based on whether more ultrasounds were done in cases of early discovery of anomalies
Measured: from 12-22 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Feb 2021
- Primary completion30 Apr 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Buskmiller, The University of Texas Health Science Center, Houston
- Investigators
- Cara Buskmiller, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639973
- Sponsor's protocol ID
- HSC-MS-20-0895
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2020
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Buskmiller C, Fishel Bartal M, Bonilla M, Denham C, Nguyen R, Sibai B, Pedroza C, Hernandez-Andrade E. First trimester anatomy ultrasound for patients with obesity: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Nov;5(11):101143. doi: 10.1016/j.ajogmf.2023.101143. Epub 2023 Sep 3.
PubMed 37669739Buskmiller C, Toates SE, Rodriguez V, Hernandez-Andrade E. A Learning Curve for First-Trimester Anatomy Ultrasound in Obese Patients. Gynecol Obstet Invest. 2024;89(4):346-350. doi: 10.1159/000538477. Epub 2024 Mar 22.
PubMed 38522420
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04639973
- Acronym / sponsor ID
- HSC-MS-20-0895
- Conditions
- Obesity
- Keywords
- pregnancy, fetal ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Posted 13 Jul 2023
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 assess the feasibility of ultrasound in the first trimester, assess the completion rate of ultrasounds for fetal anatomy in the first trimester compared to completion rates of ultrasounds for fetal anatomy in the second trimester and to assess the completion rate of the combination of one ultrasound in the first trimester and one in the second trimesters compared to the individual completion rates of both evaluations in obese pregnant women.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (First trimester ultrasound) | Experimental | Diagnostic Test: Group 1 (First trimester ultrasound) |
| Group 2 (Second trimester anatomy ultrasound) | Active comparator | Diagnostic Test: Group 2 (Second trimester anatomy ultrasound) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI greater than or equal to 35
- Presented for ultrasound before 14 weeks at The University of Texas Professional Building, Memorial City, Bellaire, or Lyndon-Baines Johnson clinics
- Primary language is English or Spanish
- Consent to an extra transvaginal ultrasound if needed
- Singleton gestation
Key exclusion criteria (3 listed)
- Elective abortion after recruitment
- Missed abortion after first trimester ultrasound
- Did not receive second trimester ultrasound
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 |
|---|---|---|
| Group 1 (First trimester ultrasound)A detailed first trimester anatomy ultrasound will be performed,at the visit when the subject is confirmed to be of eligible gestational age. After this detailed research ultrasound, which will be limited to 15 minutes, subject will then receive the clinically indicated dating ultrasound or nuchal translucency measurement. The patient will complete a survey about her satisfaction with this technique via email.as a safety measure, if an anomaly is suspected on the day of the detailed first trimester anatomy scan, the patient will be unblinded. Patients in this arm are later scheduled for a second trimester ultrasound by the clinical team, as this is part of standard obstetrical care. | Diagnostic test | Group 1 (First trimester ultrasound) |
| Group 2 (Second trimester anatomy ultrasound)Patients do not undergo a detailed first trimester ultrasound , but will receive the clinically indicated limited ultrasound for dating or for nuchal translucency. Patient will then undergoes a second trimester ultrasound by the clinical team as part of standard obstetrical care and completes a survey regarding her satisfaction with this technique via email. | Diagnostic test | Group 2 (Second trimester anatomy ultrasound) |
Primary outcome
Completion Rate for First Trimester Scans
Time frame: 12-14 weeks of pregnancy
Completion rate is reported as the number of scans that see all the views divided by total number of scans in that group
Completion Rate for Second Trimester Scans
Time frame: 18-22 weeks of pregnancy
Completion rate is reported as the number of scans that see all the views divided by total number of scans.
13 secondary outcomes
Completion Rate of First Trimester and Second Trimester Scans
Time frame: 12-22 weeks of pregnancy
Time Taken to Complete Scan in the First Trimester Ultrasound Group
Time frame: 12-14 weeks of pregnancy
Number of Anomalies Identified in First Trimester Group Scans
Time frame: 12-14 weeks of pregnancy
Number of Anomalies Identified in Second Trimester Group Scans
Time frame: 12-22 weeks of pregnancy
Number of Anomalies Missed in First Trimester Group Scans
Time frame: 12-14 weeks of pregnancy
Number of Anomalies Missed in Second Trimester Group Scans
Time frame: 12-22 weeks of pregnancy
Number of Participants With Infants Who Survive
Time frame: 9 months from randomization
Gestational Age at Delivery
Time frame: at the time of delivery (about 40 weeks of pregnancy)
Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: at the time of NICU admission (about 0 to 28 days after birth)
Hospital Length of Stay
Time frame: from time of hospital admission to discharge (about 0 to 365 days after birth)
Number of Participants With Infants With Neonatal Morbidities
Time frame: 9 months from randomization
Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans
Time frame: 6 months from randomization
Cost of Intervention Compared to Usual Care
Time frame: from 12-22 weeks of pregnancy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37669739Buskmiller C, Fishel Bartal M, Bonilla M, Denham C, Nguyen R, Sibai B, Pedroza C, Hernandez-Andrade E. First trimester anatomy ultrasound for patients with obesity: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Nov;5(11):101143. doi: 10.1016/j.ajogmf.2023.101143. Epub 2023 Sep 3.
- Results publication: PubMed 38522420Buskmiller C, Toates SE, Rodriguez V, Hernandez-Andrade E. A Learning Curve for First-Trimester Anatomy Ultrasound in Obese Patients. Gynecol Obstet Invest. 2024;89(4):346-350. doi: 10.1159/000538477. Epub 2024 Mar 22.
- 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.
Cara Buskmiller, 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 Group 1 (First trimester ultrasound) and Group 2 (Second trimester anatomy ultrasound) in people with Obesity, 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 7 inclusion and 3 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 21 May 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?
Yes. Results are posted in the registry (first posted 13 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Completion Rate for First Trimester Scans (time frame: 12-14 weeks of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04639973, which also lists 2 linked publications.
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 21 May 2024.