Assessment of Early Pregnancy MAB Completion

May 4, 2026 updated by: Lyndsey Benson, University of Washington

Assessing Completion of Medication Abortion for Very Early Pregnancies

This is a prospective study to evaluate if successful completion of a medication abortion in patients with very early pregnancy can be detected with a urine pregnancy test at 2 weeks instead of 4 weeks. Additionally, the resolution of pregnancy symptoms in these patients will be characterized. Enrolled participants will take take weekly pregnancy tests and complete weekly questionnaires on their pregnancy symptoms for 4 weeks after their medication abortion.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Carafem
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Carafem
    • Washington
      • Renton, Washington, United States, 98055
        • Cedar River Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll patients who meet the inclusion criteria at clinical sites in Washington, Georgia, and Maryland.

Description

Inclusion Criteria:

  • Pregnant person with early pregnancy ≤42 days
  • Eligible and consented to a medication abortion
  • Have access to receiving text messages and the internet
  • Able to read and understand English

Exclusion Criteria:

- Privacy or safety concerns about filling out the surveys

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Early Pregnancy
Participants with early pregnancy ≤ 42 days by last menstrual period or ultrasound undergoing a medication abortion will be enrolled.
Diagnostic test: Weekly high-sensitivity urine pregnancy tests
Participants will take a high-sensitivity urine pregnancy test at home weekly for up to 4 weeks compared to the taking just one home urine pregnancy test at 4-5 weeks. Participants will also complete short weekly questionnaires on their pregnancy symptoms and follow-up care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with negative high-sensitivity urine pregnancy test at 2 weeks
Time Frame: From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires
To estimate the proportion of negative high-sensitivity urine pregnancy tests in participants with very early pregnancy and a complete abortion at 2 weeks after taking Mifepristone and compare this proportion to the proportion of negative high-sensitivity urine pregnancy tests in participants with very early pregnancy and a complete abortion at 4 weeks
From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to resolution of pregnancy symptoms
Time Frame: From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires
To compare the timing of pregnancy symptom resolution per patient report on weekly questionnaires with the timing of a negative high-sensitivity urine pregnancy test result
From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Lyndsey Benson, MD, MS, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 9, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00022025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to study IPD will not be shared for this study due to the sensitive, private nature of the clinical care received by participants. Participant safety and confidentiality is of utmost importance for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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