Choice of Modality of Follow up for Medication Abortion
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|ClinicalTrials.gov Identifier: NCT04056637|
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2019
Last Update Posted : September 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Abortion in First Trimester||Other: Choice of follow-up option Device: Multi-level pregnancy test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Choice of Modality of Follow up for Medication Abortion|
|Actual Study Start Date :||September 9, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
No Intervention: Group 1: Standard of Care
Participants will be asked to complete follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider.
Experimental: Group 2: Flexible Follow-Up
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
Participant will be given the opportunity to choose from 3 follow-up options.
Device: Multi-level pregnancy test
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.
Other Name: dBest
- Percent follow-up after medication abortion by group [ Time Frame: 5-14 days following mifepristone administration ]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
- Percent follow-up after medication abortion by follow-up type [ Time Frame: 5-14 days following mifepristone administration ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056637
|United States, California|
|Stanford Health Care|
|Stanford, California, United States, 94305|