Assessment of Early Pregnancy MAB Completion

NCT ID: NCT06893484

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-13

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Abortion Early

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Early Pregnancy

Participants with early pregnancy ≤ 42 days by last menstrual period or ultrasound undergoing a medication abortion will be enrolled.

Weekly high-sensitivity urine pregnancy tests

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Lyndsey Benson

Assistant Professor, Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lyndsey Benson, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Carafem

Atlanta, Georgia, United States

Site Status RECRUITING

Carafem

Chevy Chase, Maryland, United States

Site Status RECRUITING

Cedar River Clinics

Renton, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Priyal Fadadu, MD, MS

Role: CONTACT

509-731-3124

Facility Contacts

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Priyal Fadadu

Role: primary

509-731-3124

Priyal Fadadu

Role: primary

509-731-3124

Priyal Fadadu

Role: primary

509-731-3124

Other Identifiers

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STUDY00022025

Identifier Type: -

Identifier Source: org_study_id

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