An interventional study of Choice of follow-up option and Multi-level pregnancy test in Abortion in First Trimester, sponsored by Stanford University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-28.
Sponsored by Stanford University · Not applicable, Interventional, and Health services research
This study will assess the impact of providing medication abortion-seeking clients a choice for follow-up in practice. Clients presenting at or less than 63 days pregnant (based on last menstrual period) at the study site for first trimester medication abortion will be invited to participate. We hypothesize that providing clients with flexible follow-up options will improve follow-up rates.
This study is not to assess efficacy or safety of follow-up methods--that has been well established in practice and research. This is to assess choice of follow-up.
Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be asked to complete follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider.
Participants will be offered three follow-up options, including: 1) follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider; 2) repeat serum beta-hCG testing; 3) repeat multi-level pregnancy test strategy
Other: Choice of follow-up option · Device: Multi-level pregnancy test
Participant will be given the opportunity to choose from 3 follow-up options.
The Multi-level pregnancy test (MLPT) strategy involves the use of the MLPT to estimate a pregnant person's baseline hCG range prior to beginning their abortion (i.e. prior to mifepristone administration). A follow-up test is then administered one week later to again estimate the woman's hCG range. A decline in hCG range reliably signifies absence of an ongoing pregnancy. Among clients ≤63 days' LMP at initiation of treatment, this strategy has shown to be highly effective: 100% of clients (n=1487/1487) with a decline in hCG range did not have an ongoing pregnancy and 100% of clients (n=21/21) with an ongoing pregnancy showed steady or increase in hCG range on their follow-up MLPT.
Also known as: dBest
Percent follow-up after medication abortion by group
To compare rates of follow-up among clients who are instructed to come back to the clinic for in-person ultrasound medication abortion follow-up to clients who are given options for follow-up, including in-person ultrasound, repeat serum beta-hCG and MLPT
Time frame: 5-14 days following mifepristone administration
Percent follow-up after medication abortion by follow-up type
To compare the overall proportion of follow-up completion among clients choosing their preferred method of follow-up (in-person ultrasound, repeat serum beta-hCG, MLPT strategy) (study period) to clients given only the option for in-person follow-up
Time frame: 5-14 days following mifepristone administration
Plan to share: No — No data will be shared.
No publications or documents are linked to this record.
This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Stanford University