Choice of Modality of Follow up for Medication Abortion

Stanford University26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Abortion in First Trimester

Interventions

Choice of follow-up optionOTHER

Participant will be given the opportunity to choose from 3 follow-up options.

Multi-level pregnancy testDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stanford Health Care

Stanford, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.