Choice of Modality of Follow up for Medication Abortion

NCT04056637 | Terminated

• 1 other identifier: 52312
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion in First Trimester

Keywords

MLPT; multi-level pregnancy test; medication abortion; first trimester abortion; abortion follow-up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percent follow-up after medication abortion by follow-up type

  5-14 days following mifepristone administration

Study Arms (2)

Group 1: Standard of Care

NO INTERVENTION

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

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; Device: Multi-level pregnancy test

Interventions

Choice of follow-up option OTHER

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

Group 2: Flexible Follow-Up

Multi-level pregnancy test DEVICE

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.

Also known as: dBest

Group 2: Flexible Follow-Up

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for medication abortion \<63 days gestational age
• In general good health
• English or Spanish speaking competency
• Willing and able to sign consent forms

You may not qualify if:

• Clients less than 18 years of age.

Sponsors & Collaborators

• Stanford University: lead
• Gynuity Health Projects: collaborator

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: September 9, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 31, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)