Home Follow-up After Medication Abortion

Summary

This study aims to evaluate a home follow-up alternative after medication abortion with pregnancy testing and a completion test. Clinical evaluation after a medication abortion (MAB) is standard of care to diagnose continued pregnancy and treat complications, typically done with a provider and an ultrasound examination or serial blood testing. Follow-up rates in the literature after MAB have been found to be 51% to 77% in recent literature using these standard follow-up methods. Though medication abortion is highly efficient, the on-going pregnancy rate is about 4% for pregnancies with gestational age up to 70 days from last menstrual period, thus highlighting the importance of follow-up as patients may not know they have a continued pregnancy weeks to even months after taking medication for an abortion. The investigators plan on providing participants with the option of a home follow-up option versus the standard of care (clinic) option. The primary objective of this study is looking at follow-up rates by each of these groups. As more options are provided for follow-up to patients, it is hoped that follow-up rates will improve and reduce the burdens of clinic visits on both providers and patients, ultimately making continued pregnancy after a medication abortion a never event.

Conditions

• Medical; Abortion, Fetus

Interventions

OTHER

Follow-up clinic visit

Participants will be scheduled for a visit with a provider in 1-2 weeks that will include an ultrasound examination.

OTHER

Text message

Participants will be instructed that they will be contacted by research staff through text message 14 days after the initial visit. They will receive a survey link through text message at this time.

OTHER

Low Sensitivity Pregnancy Test (LSPT)

Participants will be instructed on how to test their urine 14 days after the medication abortion for continued pregnancy. LSPT can detect hCG levels as low as 2000 mIU/ml.

Sponsors & Collaborators

• Society of Family Planning

  collaborator OTHER

• Boston Medical Center

  lead OTHER

Principal Investigators

• Cara Delaney, MD · Boston Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-31

Primary Completion

2021-05-31

Completion

2021-05-31