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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (First trimester ultrasound) | Experimental |
| |
| Group 2 (Second trimester anatomy ultrasound) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 18-22 weeks of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12-22 weeks of pregnancy |
| Time Taken to Complete Scan in the First Trimester Ultrasound Group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cara Buskmiller, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37669739 | Result | 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. | |
| 38522420 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (First Trimester Ultrasound) | 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. |
| FG001 | Group 2 (Second Trimester Anatomy 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data were not collected from one participant in the group 1 (first trimester ultrasound) arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (First Trimester Ultrasound) | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | percent | 12-14 weeks of pregnancy |
|
From time of enrollment until neonatal discharge from hospital (from about 12 weeks of pregnancy to 365 days after birth)
Data were not collected from one participant in the group 1 (first trimester ultrasound) arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 (First Trimester Ultrasound) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cara Buskmiller, MD | Baylor College of Medicine | 832-824-1000 | cara.buskmiller@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2021 | Apr 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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. |
|
| 12-14 weeks of pregnancy |
| Number of Anomalies Identified in First Trimester Group Scans | 12-14 weeks of pregnancy |
| Number of Anomalies Identified in Second Trimester Group Scans | 12-22 weeks of pregnancy |
| Number of Anomalies Missed in First Trimester Group Scans | 12-14 weeks of pregnancy |
| Number of Anomalies Missed in Second Trimester Group Scans | 12-22 weeks of pregnancy |
| Number of Participants With Infants Who Survive | 9 months from randomization |
| Gestational Age at Delivery | at the time of delivery (about 40 weeks of pregnancy) |
| Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU) | at the time of NICU admission (about 0 to 28 days after birth) |
| Hospital Length of Stay | 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 | 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.
| 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 | from 12-22 weeks of pregnancy |
| Buskmiller 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. |
| BG001 | Group 2 (Second Trimester Anatomy 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Insurance | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Pre-pregnancy Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Number of participants with Chronic Hypertension | Count of Participants | Participants |
|
| Gestational age at enrollment | Median | Inter-Quartile Range | weeks |
|
| Gestational age at anatomy scan | Median | Inter-Quartile Range | weeks |
|
| Number of Participants with Type 2 Diabetes Mellitus | Count of Participants | Participants |
|
| Parity | number of completed pregnancies beyond 20 weeks gestation (whether viable or nonviable) | Median | Inter-Quartile Range | completed pregnancies |
|
| Number of Pre-term births | Pre-term birth is defined as babies born alive before 37 weeks of pregnancy are completed. | Median | Inter-Quartile Range | pre-term births |
|
|
|
| Primary | 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. | Posted | Number | percent | 18-22 weeks of pregnancy |
|
|
|
| Secondary | 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). | Data was not collected from 62 participants in the Group 2 (second trimester anatomy ultrasound) arm. | Posted | Number | percent | 12-22 weeks of pregnancy |
|
|
|
| Secondary | Time Taken to Complete Scan in the First Trimester Ultrasound Group | Posted | Mean | Standard Deviation | minutes | 12-14 weeks of pregnancy |
|
|
|
| Secondary | Number of Anomalies Identified in First Trimester Group Scans | Posted | Number | anomalies | 12-14 weeks of pregnancy |
|
|
|
| Secondary | Number of Anomalies Identified in Second Trimester Group Scans | Posted | Number | anomalies | 12-22 weeks of pregnancy |
|
|
|
| Secondary | Number of Anomalies Missed in First Trimester Group Scans | Posted | Number | anomalies | 12-14 weeks of pregnancy |
|
|
|
| Secondary | Number of Anomalies Missed in Second Trimester Group Scans | Posted | Number | anomalies | 12-22 weeks of pregnancy |
|
|
|
| Secondary | Number of Participants With Infants Who Survive | Data was not collected from 4 participants in the Group 1 (first trimester ultrasound) arm. Data was not collected from 2 participants in the Group 2 (second trimester anatomy ultrasound) arm. | Posted | Count of Participants | Participants | 9 months from randomization |
|
|
|
| Secondary | Gestational Age at Delivery | Data was not collected from 5 participants in the Group 1 (first trimester ultrasound) arm. Data was not collected from 2 participants in the Group 2 (second trimester anatomy ultrasound) arm. | Posted | Median | Inter-Quartile Range | weeks | at the time of delivery (about 40 weeks of pregnancy) |
|
|
|
| Secondary | Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU) | Data was not collected from 5 participants in the Group 1 (first trimester ultrasound) arm. Data was not collected from 2 participants in the Group 2 (second trimester anatomy ultrasound) arm. | Posted | Count of Participants | Participants | at the time of NICU admission (about 0 to 28 days after birth) |
|
|
|
| Secondary | Hospital Length of Stay | Data was not collected from 5 participants in the Group 1 (first trimester ultrasound) arm. Data was not collected from 2 participants in the Group 2 (second trimester anatomy ultrasound) arm. | Posted | Median | Inter-Quartile Range | days | from time of hospital admission to discharge (about 0 to 365 days after birth) |
|
|
|
| Secondary | Number of Participants With Infants With Neonatal Morbidities | Neonatal morbidities include hypoglycemia | Data was not collected from 5 participants in the Group 1 (first trimester ultrasound) arm. Data was not collected from 2 participants in the Group 2 (second trimester anatomy ultrasound) arm. | Posted | Count of Participants | Participants | 9 months from randomization |
|
|
|
| Secondary | 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.
| Data was not collected from 32 participants in the Group 1 (first trimester ultrasound) arm. Data was not collected from 62 participants in the Group 2 (second trimester anatomy ultrasound) arm. | Posted | Count of Participants | Participants | 6 months from randomization |
|
|
|
| Secondary | Cost of Intervention Compared to Usual Care | cost benefit analysis based on whether more ultrasounds were done in cases of early discovery of anomalies | Data were not collected for this outcome measure | Posted | from 12-22 weeks of pregnancy |
|
|
| 0 |
| 64 |
| 5 |
| 64 |
| 0 |
| 64 |
| EG001 | Group 2 (Second Trimester Anatomy 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. | 0 | 63 | 1 | 63 | 0 | 63 |
| Fetal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Neonatal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |