Trial Outcomes & Findings for Transabdominal and Transvaginal Sonography in Medical Abortion (NCT NCT03047551)
NCT ID: NCT03047551
Last Updated: 2019-09-30
Results Overview
Evaluate how often a provider orders additional testing prior to medical abortion, but after either 1) patient history and TAS or 2) patient history and TVS.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
634 participants
Primary outcome timeframe
1 day
Results posted on
2019-09-30
Participant Flow
Subjects were excluded from the analysis due to study withdrawal prior to receiving sonography.
Participant milestones
| Measure |
Transabdominal Sonography
Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility.
A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.
Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
Transvaginal Sonography
Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility.
Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.
Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
|---|---|---|
|
Overall Study
STARTED
|
319
|
315
|
|
Overall Study
COMPLETED
|
317
|
312
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Transabdominal Sonography
Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility.
A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.
Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
Transvaginal Sonography
Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility.
Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.
Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
|---|---|---|
|
Overall Study
Did not receive TAS
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Probe malfunction
|
0
|
1
|
|
Overall Study
Ineligible
|
0
|
1
|
Baseline Characteristics
Transabdominal and Transvaginal Sonography in Medical Abortion
Baseline characteristics by cohort
| Measure |
Transabdominal Sonography
n=317 Participants
Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility.
A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.
Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
Transvaginal Sonography
n=312 Participants
Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility.
Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.
Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
Total
n=629 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
317 Participants
n=93 Participants
|
312 Participants
n=4 Participants
|
629 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
317 Participants
n=93 Participants
|
312 Participants
n=4 Participants
|
629 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
|
179 Participants
n=93 Participants
|
168 Participants
n=4 Participants
|
347 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=93 Participants
|
123 Participants
n=4 Participants
|
237 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
317 participants
n=93 Participants
|
312 participants
n=4 Participants
|
629 participants
n=27 Participants
|
|
BMI category
<25 kg/m^2
|
143 Participants
n=93 Participants
|
135 Participants
n=4 Participants
|
278 Participants
n=27 Participants
|
|
BMI category
25 - <30 kg/m^2
|
99 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
181 Participants
n=27 Participants
|
|
BMI category
30 - <35 kg/m^2
|
49 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
|
BMI category
>35 kg/m^2
|
17 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
BMI category
Missing
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 dayEvaluate how often a provider orders additional testing prior to medical abortion, but after either 1) patient history and TAS or 2) patient history and TVS.
Outcome measures
| Measure |
Transabdominal Sonography
n=317 Participants
Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility.
A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.
Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
Transvaginal Sonography
n=312 Participants
Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility.
Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.
Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
|---|---|---|
|
Percentage of Subjects in Each Ultrasound Group With Additional Testing
|
63 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 1 dayTo measure patient satisfaction after ultrasound examination, each participant will complete an acceptability questionnaire regarding the type of ultrasound she received (TVS or TAS) using a visual analog scale (VAS). The score is on a scale range of 0-100, with 0 being "unacceptable" and 100 being "acceptable." Thus, higher scores are better.
Outcome measures
| Measure |
Transabdominal Sonography
n=317 Participants
Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility.
A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.
Transabdominal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
Transvaginal Sonography
n=312 Participants
Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility.
Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.
Transvaginal sonography: Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
|
|---|---|---|
|
Visual Analog Scale (VAS) Score for Patient Acceptability for Either Modality of Ultrasound
|
95.9 score on a scale
Interval 17.0 to 100.0
|
90.0 score on a scale
Interval 0.0 to 100.0
|
Adverse Events
Transabdominal Sonography
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transvaginal Sonography
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place