Assessment of Early Pregnancy MAB Completion

NCT06893484 | Recruiting

• 1 other identifier: STUDY00022025
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pregnancy; Abortion Early

Keywords

very early pregnancy; pregnancy test

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with negative high-sensitivity urine pregnancy test at 2 weeks

  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 Outcomes (1)

• Time to resolution of pregnancy symptoms

  From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires

Study Arms (1)

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

Interventions

Weekly high-sensitivity urine pregnancy tests DIAGNOSTIC_TEST

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.

Participants with Early Pregnancy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Privacy or safety concerns about filling out the surveys

Sponsors & Collaborators

• University of Washington: lead

Study Sites (3)

Carafem

Atlanta, Georgia, 30309, United States

RECRUITING

Carafem

Chevy Chase, Maryland, 20815, United States

RECRUITING

Cedar River Clinics

Renton, Washington, 98055, United States

RECRUITING

Study Officials

• Lyndsey Benson, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priyal Fadadu, MD, MS

CONTACT

509-731-3124; fpstudy@uw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Obstetrics & Gynecology

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 25, 2025
• Study Start: March 13, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)