Abortion in First Trimester
Conditions
Keywords
MLPT, multi-level pregnancy test, medication abortion, first trimester abortion, abortion follow-up
Brief summary
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.
Interventions
OTHERChoice of follow-up option
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.
Sponsors
Gynuity Health Projects
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent follow-up after medication abortion by group | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent follow-up after medication abortion by follow-up type | 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 |
Countries
United States
Outcome results
None listed