Choice of Modality of Follow up for Medication Abortion

Stanford University

Status: Terminated

Conditions: Abortion in First Trimester

Treatments: Device: Multi-level pregnancy test; Other: Choice of follow-up option

Study type: Interventional

Funder types: Other

Identifiers

NCT04056637

52312

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Group 1: Standard of Care

No Intervention group

Description:

Participants will be asked to complete follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider.

Group 2: Flexible Follow-Up

Experimental group

Description:

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

Treatment:

Other: Choice of follow-up option

Device: Multi-level pregnancy test