Obesity
Conditions
Keywords
pregnancy, fetal ultrasound
Brief 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 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.
Interventions
DIAGNOSTIC_TESTGroup 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_TESTGroup 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Elective abortion after recruitment * Missed abortion after first trimester ultrasound * Did not receive second trimester ultrasound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate for First Trimester Scans | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Completion Rate of First Trimester and Second Trimester Scans | 12-22 weeks of pregnancy | 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). |
| 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 | 9 months from randomization | Neonatal morbidities include hypoglycemia |
| Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans | 6 months from randomization | 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. 1. Very satisfied 2. Somewhat satisfied 3. Neither satisfied nor dissatisfied 4. Somewhat dissatisfied 5. Very dissatisfied |
| Cost of Intervention Compared to Usual Care | from 12-22 weeks of pregnancy | cost benefit analysis based on whether more ultrasounds were done in cases of early discovery of anomalies |
| Gestational Age at Delivery | at the time of delivery (about 40 weeks of pregnancy) | — |
| Time Taken to Complete Scan in the First Trimester Ultrasound Group | 12-14 weeks of pregnancy | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 64 |
| 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. | 63 |
| Total | 127 |
Baseline characteristics
| Characteristic | Group 1 (First Trimester Ultrasound) | Group 2 (Second Trimester Anatomy Ultrasound) | Total |
|---|---|---|---|
| Age, Continuous | 30.3 years | 30.9 years | 30.8 years |
| Education college graduate | 12 Participants | 14 Participants | 26 Participants |
| Education Highschool/GED | 14 Participants | 16 Participants | 30 Participants |
| Education less than highschool | 4 Participants | 1 Participants | 5 Participants |
| Education post graduate | 2 Participants | 5 Participants | 7 Participants |
| Education some college | 19 Participants | 17 Participants | 36 Participants |
| Education unknown | 13 Participants | 10 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 26 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 35 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Gestational age at anatomy scan | 13.3 weeks | 20.4 weeks | 18.8 weeks |
| Gestational age at enrollment | 10.14 weeks | 11.00 weeks | 10.7 weeks |
| Insurance government assisted | 37 Participants | 40 Participants | 77 Participants |
| Insurance no insurance | 0 Participants | 1 Participants | 1 Participants |
| Insurance private | 26 Participants | 21 Participants | 47 Participants |
| Insurance self pay | 1 Participants | 1 Participants | 2 Participants |
| Marital Status Married | 32 Participants | 34 Participants | 66 Participants |
| Marital Status Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Marital Status Separated | 1 Participants | 1 Participants | 2 Participants |
| Marital Status Single | 29 Participants | 24 Participants | 53 Participants |
| Number of participants with Chronic Hypertension | 18 Participants | 11 Participants | 29 Participants |
| Number of Participants with Type 2 Diabetes Mellitus | 14 Participants | 4 Participants | 18 Participants |
| Number of Pre-term births | 0 pre-term births | 0 pre-term births | 0 pre-term births |
| Parity | 1 completed pregnancies | 1 completed pregnancies | 1 completed pregnancies |
| Pre-pregnancy Body Mass Index | 40 kg/m^2 | 40 kg/m^2 | 40 kg/m^2 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 30 Participants | 27 Participants | 57 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 10 Participants | 6 Participants | 16 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 21 Participants | 30 Participants | 51 Participants |
| Region of Enrollment United States | 64 participants | 63 participants | 127 participants |
| Sex: Female, Male Female | 64 Participants | 63 Participants | 127 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 63 |
| other Total, other adverse events | 0 / 64 | 0 / 63 |
| serious Total, serious adverse events | 5 / 64 | 1 / 63 |
Outcome results
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
Time frame: 12-14 weeks of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Completion Rate for First Trimester Scans | 66 percent |
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.
Time frame: 18-22 weeks of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Completion Rate for Second Trimester Scans | 53 percent |
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).
Time frame: 12-22 weeks of pregnancy
Population: Data was not collected from 62 participants in the Group 2 (second trimester anatomy ultrasound) arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Completion Rate of First Trimester and Second Trimester Scans | 82.8 percent |
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
Time frame: from 12-22 weeks of pregnancy
Population: Data were not collected for this outcome measure
Secondary
Gestational Age at Delivery
Time frame: at the time of delivery (about 40 weeks of pregnancy)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Gestational Age at Delivery | 37.4 weeks |
| Group 2 (Second Trimester Anatomy Ultrasound) | Gestational Age at Delivery | 37.5 weeks |
Secondary
Hospital Length of Stay
Time frame: from time of hospital admission to discharge (about 0 to 365 days after birth)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Hospital Length of Stay | 8 days |
| Group 2 (Second Trimester Anatomy Ultrasound) | Hospital Length of Stay | 18 days |
Secondary
Number of Anomalies Identified in First Trimester Group Scans
Time frame: 12-14 weeks of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Number of Anomalies Identified in First Trimester Group Scans | 5 anomalies |
Secondary
Number of Anomalies Identified in Second Trimester Group Scans
Time frame: 12-22 weeks of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Number of Anomalies Identified in Second Trimester Group Scans | 6 anomalies |
Secondary
Number of Anomalies Missed in First Trimester Group Scans
Time frame: 12-14 weeks of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Number of Anomalies Missed in First Trimester Group Scans | 3 anomalies |
Secondary
Number of Anomalies Missed in Second Trimester Group Scans
Time frame: 12-22 weeks of pregnancy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Number of Anomalies Missed in Second Trimester Group Scans | 0 anomalies |
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. 1. Very satisfied 2. Somewhat satisfied 3. Neither satisfied nor dissatisfied 4. Somewhat dissatisfied 5. Very dissatisfied
Time frame: 6 months from randomization
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans | 30 Participants |
Secondary
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)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU) | 18 Participants |
| Group 2 (Second Trimester Anatomy Ultrasound) | Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU) | 8 Participants |
Secondary
Number of Participants With Infants Who Survive
Time frame: 9 months from randomization
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Number of Participants With Infants Who Survive | 57 Participants |
| Group 2 (Second Trimester Anatomy Ultrasound) | Number of Participants With Infants Who Survive | 60 Participants |
Secondary
Number of Participants With Infants With Neonatal Morbidities
Neonatal morbidities include hypoglycemia
Time frame: 9 months from randomization
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (First Trimester Ultrasound) | Number of Participants With Infants With Neonatal Morbidities | 9 Participants |
| Group 2 (Second Trimester Anatomy Ultrasound) | Number of Participants With Infants With Neonatal Morbidities | 3 Participants |
Secondary
Time Taken to Complete Scan in the First Trimester Ultrasound Group
Time frame: 12-14 weeks of pregnancy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (First Trimester Ultrasound) | Time Taken to Complete Scan in the First Trimester Ultrasound Group | 65 minutes | Standard Deviation 27 |