Abortion Early Clinical Trial
— TASvTVSOfficial title:
Is Transabdominal Sonography Comparable to Transvaginal Sonography for Eligibility Assessment Prior to Medical Abortion? A Randomized Controlled Trial.
NCT number | NCT03047551 |
Other study ID # | AAAQ8722 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | June 2018 |
Verified date | September 2019 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigator will perform a multicenter, randomized controlled trial in practices that
routinely use transvaginal sonography (TVS) to compare how often clinicians order additional
testing prior to medical abortion after the use of either TVS or transabdominal ultrasound
(TAS) in medical abortion eligibility assessment. Women will be randomized to receive either
TVS or TAS prior to medical abortion. We anticipate enrolling 800 patients receiving care
from about 30 providers over 6-8 months.
The primary study outcome will be the proportion of women that requires additional evaluation
after sonography, prior to determination of medical abortion eligibility. The second primary
outcome will be patient satisfaction, determined by a patient satisfaction questionnaire
utilizing a visual analog scale.
Status | Completed |
Enrollment | 634 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - English- or Spanish- speaking women seeking medical abortion - 18 years or older - Women at an estimated gestational age up to 70 days from last menstrual period (LMP) Exclusion Criteria: - Women under 18 years old - Women at an estimated gestational age greater than 70 days from LMP at enrollment |
Country | Name | City | State |
---|---|---|---|
United States | Planned Parenthood of Northern, Central, and Southern New Jersey | Morristown | New Jersey |
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
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* Note: There are 56 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects in Each Ultrasound Group With Additional Testing | 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. | 1 day | |
Primary | Visual Analog Scale (VAS) Score for Patient Acceptability for Either Modality of Ultrasound | To 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. | 1 day |
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