Choice of Modality of Follow up for Medication Abortion

Study Overview
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Brief Summary
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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.

Official Title
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Choice of Modality of Follow up for Medication Abortion

Conditions
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Abortion in First Trimester

Intervention / Treatment
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* Other: Choice of follow-up option
* Device: Multi-level pregnancy test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for medication abortion <63 days gestational age In general good health English or Spanish speaking competency Willing and able to sign consent forms Exclusion Criteria: Clients less than 18 years of age. Any client not meeting the inclusion criteria listed above will be excluded from participating in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1: Standard of Care<br>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<br>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<br>* Participant will be given the opportunity to choose from 3 follow-up options.<br>Device: Multi-level pregnancy test<br>* 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.<br>* Other names: dBest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5-14 days following mifepristone administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5-14 days following mifepristone administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MLPT, multi-level pregnancy test, medication abortion, first trimester abortion, abortion follow-up