Trial Outcomes & Findings for Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O) (NCT NCT04639973)
NCT ID: NCT04639973
Last Updated: 2024-05-21
Results Overview
Completion rate is reported as the number of scans that see all the views divided by total number of scans in that group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
12-14 weeks of pregnancy
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
63
|
|
Overall Study
COMPLETED
|
62
|
62
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O)
Baseline characteristics by cohort
| Measure |
Group 1 (First Trimester Ultrasound)
n=64 Participants
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.
|
Group 2 (Second Trimester Anatomy Ultrasound)
n=63 Participants
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.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.3 years
n=93 Participants
|
30.9 years
n=4 Participants
|
30.8 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
127 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
30 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
10 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=93 Participants
|
63 participants
n=4 Participants
|
127 participants
n=27 Participants
|
|
Insurance
private
|
26 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Insurance
government assisted
|
37 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
Insurance
self pay
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Insurance
no insurance
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Marital Status
Single
|
29 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
|
Marital Status
Separated
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Marital Status
Married
|
32 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Marital Status
Not Reported
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Education
less than highschool
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Education
Highschool/GED
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Education
some college
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Education
college graduate
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Education
post graduate
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Education
unknown
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Pre-pregnancy Body Mass Index
|
40 kg/m^2
n=93 Participants
|
40 kg/m^2
n=4 Participants
|
40 kg/m^2
n=27 Participants
|
|
Number of participants with Chronic Hypertension
|
18 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Gestational age at enrollment
|
10.14 weeks
n=93 Participants
|
11.00 weeks
n=4 Participants
|
10.7 weeks
n=27 Participants
|
|
Gestational age at anatomy scan
|
13.3 weeks
n=93 Participants
|
20.4 weeks
n=4 Participants
|
18.8 weeks
n=27 Participants
|
|
Number of Participants with Type 2 Diabetes Mellitus
|
14 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Parity
|
1 completed pregnancies
n=93 Participants
|
1 completed pregnancies
n=4 Participants
|
1 completed pregnancies
n=27 Participants
|
|
Number of Pre-term births
|
0 pre-term births
n=93 Participants
|
0 pre-term births
n=4 Participants
|
0 pre-term births
n=27 Participants
|
PRIMARY outcome
Timeframe: 12-14 weeks of pregnancyCompletion rate is reported as the number of scans that see all the views divided by total number of scans in that group
Outcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=62 Participants
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.
|
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.
|
|---|---|---|
|
Completion Rate for First Trimester Scans
|
66 percent
|
—
|
PRIMARY outcome
Timeframe: 18-22 weeks of pregnancyCompletion rate is reported as the number of scans that see all the views divided by total number of scans.
Outcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=62 Participants
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.
|
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.
|
|---|---|---|
|
Completion Rate for Second Trimester Scans
|
53 percent
|
—
|
SECONDARY outcome
Timeframe: 12-22 weeks of pregnancyPopulation: Data was not collected from 62 participants in the Group 2 (second trimester anatomy ultrasound) arm.
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).
Outcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=62 Participants
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.
|
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.
|
|---|---|---|
|
Completion Rate of First Trimester and Second Trimester Scans
|
82.8 percent
|
—
|
SECONDARY outcome
Timeframe: 12-14 weeks of pregnancyOutcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=62 Participants
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.
|
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.
|
|---|---|---|
|
Time Taken to Complete Scan in the First Trimester Ultrasound Group
|
65 minutes
Standard Deviation 27
|
—
|
SECONDARY outcome
Timeframe: 12-14 weeks of pregnancyOutcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=62 Participants
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.
|
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.
|
|---|---|---|
|
Number of Anomalies Identified in First Trimester Group Scans
|
5 anomalies
|
—
|
SECONDARY outcome
Timeframe: 12-22 weeks of pregnancyOutcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=62 Participants
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.
|
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.
|
|---|---|---|
|
Number of Anomalies Identified in Second Trimester Group Scans
|
6 anomalies
|
—
|
SECONDARY outcome
Timeframe: 12-14 weeks of pregnancyOutcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=62 Participants
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.
|
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.
|
|---|---|---|
|
Number of Anomalies Missed in First Trimester Group Scans
|
3 anomalies
|
—
|
SECONDARY outcome
Timeframe: 12-22 weeks of pregnancyOutcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=62 Participants
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.
|
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.
|
|---|---|---|
|
Number of Anomalies Missed in Second Trimester Group Scans
|
0 anomalies
|
—
|
SECONDARY outcome
Timeframe: 9 months from randomizationPopulation: 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.
Outcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=58 Participants
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.
|
Group 2 (Second Trimester Anatomy Ultrasound)
n=60 Participants
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.
|
|---|---|---|
|
Number of Participants With Infants Who Survive
|
57 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=57 Participants
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.
|
Group 2 (Second Trimester Anatomy Ultrasound)
n=60 Participants
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.
|
|---|---|---|
|
Gestational Age at Delivery
|
37.4 weeks
Interval 34.9 to 38.9
|
37.5 weeks
Interval 36.7 to 38.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=57 Participants
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.
|
Group 2 (Second Trimester Anatomy Ultrasound)
n=60 Participants
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.
|
|---|---|---|
|
Number of Participants With Infants Admitted to the Neonatal Intensive Care Unit (NICU)
|
18 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=57 Participants
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.
|
Group 2 (Second Trimester Anatomy Ultrasound)
n=60 Participants
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.
|
|---|---|---|
|
Hospital Length of Stay
|
8 days
Interval 4.5 to 16.5
|
18 days
Interval 8.5 to 25.5
|
SECONDARY outcome
Timeframe: 9 months from randomizationPopulation: 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.
Neonatal morbidities include hypoglycemia
Outcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=57 Participants
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.
|
Group 2 (Second Trimester Anatomy Ultrasound)
n=60 Participants
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.
|
|---|---|---|
|
Number of Participants With Infants With Neonatal Morbidities
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 months from randomizationPopulation: 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.
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
Outcome measures
| Measure |
Group 1 (First Trimester Ultrasound)
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants Who Were Very Satisfied With Ultrasound as Measured by the Standardized Survey in the First Trimester Group Scans
|
30 Participants
|
—
|
SECONDARY outcome
Timeframe: from 12-22 weeks of pregnancyPopulation: Data were not collected for this outcome measure
cost benefit analysis based on whether more ultrasounds were done in cases of early discovery of anomalies
Outcome measures
Outcome data not reported
Adverse Events
Group 1 (First Trimester Ultrasound)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (Second Trimester Anatomy Ultrasound)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (First Trimester Ultrasound)
n=64 participants at risk
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.
|
Group 2 (Second Trimester Anatomy Ultrasound)
n=63 participants at risk
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.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
4.7%
3/64 • Number of events 3 • 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.
|
0.00%
0/63 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal death
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1.6%
1/64 • Number of events 1 • 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.
|
1.6%
1/63 • Number of events 1 • 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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Pregnancy, puerperium and perinatal conditions
Neonatal death
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1.6%
1/64 • Number of events 1 • 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.
|
0.00%
0/63 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place