Abortion Early Clinical Trial
Official title:
Is Transabdominal Sonography Comparable to Transvaginal Sonography for Eligibility Assessment Prior to Medical Abortion? A Randomized Controlled Trial.
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.
Ultrasound use in the assessment of medical abortion eligibility varies by practice site. The
National Abortion Federation (NAF), the Society of Family Planning (SFP), and the World
Health Organization (WHO) guidelines do not recommend routine use of sonography; however,
many institutions and practices still require this as part of clinic protocol. Many
clinicians routinely perform transvaginal sonography (TVS), a more invasive assessment than
transabdominal ultrasound (TAS); reliance on TVS, specifically, can be cost-prohibitive due
to high-level disinfection (HLD) requirements. Thus, routine US use can greatly decrease
access to abortion services.
Medical abortion accounts for an increasing proportion of abortions performed in the United
States; as of 2012, 20.8% of all abortions were medical abortions. Routine use of
ultrasonography and particularly TVS may be a holdover secondary to its use in early clinical
trials of medical abortion efficacy - its use has remained a part of many providers' clinical
practice despite evidence that it is not always necessary.
This study, specifically, would be of value for the many clinicians who currently use TVS for
all medical abortion patients and could support using TAS rather than TVS in a majority of
these patients. The results could also provide guidance on how often practice settings
without TVS and HLD would be able to provide medical abortion, and for which patients. Such
settings could include primary care or rural clinics, any low volume clinics, or those where
the costs and time associated with the HLD required for use of TVS prohibit or limit the
provision of medical abortion. In addition, even high-volume specialty family planning
clinics would benefit from a reduction in use of TVS. In the US, many providers have
sonography available and use it routinely. However, even in the US, many clinics may seek to
offer medical abortion without sonography, and other researchers are studying this type of
approach. This proposed study will evaluate a more intermediate change in practice, primarily
geared towards the large number of providers who routinely provide transvaginal ultrasound.
For those providers, moving from TVS to TAS could be both cost effective and acceptable to
patients.
In detail, the study will enroll patients presenting for medical abortion at multiple
clinical sites. These women will undergo routine intake per usual clinical protocol, then
randomized to receive either TVS or TAS. Afterwards, routine clinical care will be provided
by the clinician, which can include medical abortion provision or further testing to
determine eligibility. Women will complete an acceptability survey at the conclusion of the
visit.
For providers, prior to participation, providers will complete a questionnaire regarding
professional characteristics. Investigators will provide a training session for all providers
at each site to review TAS (i.e., techniques and standardized reporting) assuming some
providers have less experience with this when compared to TVS in early pregnancy. This
training session will help minimize differences in TVS and TAS related to provider experience
or variability in current practice. In addition, prior to participant enrollment, each clinic
site will enroll 5 pilot patients, during which providers will perform only TAS to accustom
providers and clinic staff to study protocols. Each clinician will perform TAS on at least 2
but no more than 5 pilot patients.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03989869 -
Very Early Medical Abortion
|
N/A | |
Active, not recruiting |
NCT03736681 -
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage
|
Phase 1 | |
Completed |
NCT03636451 -
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
|
Phase 3 | |
Recruiting |
NCT05182008 -
A Patient Decision Aid for Method of Early Abortion: A Randomized Control Trial
|
N/A | |
Completed |
NCT04432792 -
The California Home Abortion by Telehealth (CHAT) Study
|
||
Completed |
NCT03417362 -
Delivery of Audiovisual Information on Early Medical Abortion
|
N/A | |
Completed |
NCT04824118 -
Clotting Parameters After Medical Abortion
|
||
Recruiting |
NCT04458558 -
Improving Access to Abortion in the Republic of Georgia
|
Phase 4 | |
Active, not recruiting |
NCT05278780 -
Medication Abortion With Autonomous Self-Assessment Project
|
N/A | |
Completed |
NCT03320057 -
Medication Abortion Via Pharmacy Dispensing
|
Phase 4 | |
Not yet recruiting |
NCT05986357 -
The Relation of High Sensitivity C Reactive Protein and Total Leucocytic Count Levels in Threatened Abortion
|
||
Completed |
NCT03913104 -
Mail Order Mifepristone Study
|
Phase 4 | |
Terminated |
NCT04139382 -
Using Telemedicine to Improve Early Medical Abortion at Home
|
N/A | |
Recruiting |
NCT05147857 -
Mid Trimester Abortion Effectiveness by Dilapan s
|
N/A | |
Recruiting |
NCT05781061 -
MA-ASAP at Independent Abortion Clinics: A Demonstration Project
|
N/A | |
Completed |
NCT02522078 -
Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion
|
Phase 4 | |
Completed |
NCT05635955 -
Remimazolam Versus Propofol for Painless Abortion
|
Phase 2 | |
Active, not recruiting |
NCT05342974 -
Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy
|
Early Phase 1 | |
Completed |
NCT03900728 -
Auriculotherapy During Medication Abortion
|
N/A |