Home Follow-up After Medication Abortion

Feasibility of Home Follow-up After Medication Abortion (MAB)

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.

Study Overview

• Status: Withdrawn
• Conditions: Medical; Abortion, Fetus
• Intervention / Treatment: Other: Follow-up clinic visit; Other: Text message; Other: Low Sensitivity Pregnancy Test (LSPT)

Detailed Description

The primary objective of this research is to determine if introducing home follow-up will improve follow-up rates after medication abortion

Secondary objectives of the study are to:

• assess the feasibility of mobile phone text messaging with low sensitivity pregnancy testing for home follow-up after medication abortion
• assess the acceptability of chosen follow-up after medication abortion
• determine the complication rate, emergency room visit rate, and ongoing pregnancy rate after home follow-up

This prospective cohort study will be carried out at a single, urban hospital-based abortion clinic exploring the feasibility and acceptability of home follow-up after medication abortion with text messaging and a Low Sensitivity Pregnancy Test (LSPT). Participants will be recruited from a single abortion practice at Boston Medical Center (BMC) in Boston, Massachusetts. This clinic serves a multi-ethnic population from the South Boston area, with most patients English and Spanish speaking and covered by public insurance. Abortion care is provided by obstetrics and gynecology residents, family planning fellows, nurse practitioners, and family planning doctors.

As part of the study participants will be given the choice to have clinic follow-up or home follow-up. The clinic follow-up cohort will receive our clinic standard of care - they will be scheduled for a visit with a provider in 1-2 weeks that will include an ultrasound examination. This cohort will be asked the same questions to assess completion that will be asked of the home follow-up group.

Participants enrolled in the home follow-up group will be instructed that they will be contacted by research staff through text message 14 days after the initial visit. At enrollment, they will receive instruction for when the study team will be contacting them, how to use the LSPT, as well as the test itself. The participant will take the pregnancy test at home in 14 days and answer completion questions by text message for follow-up. Patients that screen positive will be asked to return to clinic for a visit with a provider.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• English or Spanish speakers
• Have a working phone they consider their own with text messaging capabilities
• Have a viable intrauterine pregnancy
• Are eligible for a medication abortion (10 weeks gestational age or less)
• Elect the method of medication abortion

Exclusion Criteria:

-None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Clinic follow-up group; All participants in this group will receive the standard of care at BMC which includes receiving a follow-up visit date and time before leaving the initial visit, when they receive the medications for abortion. Patients then return to clinic 1-2 weeks later to be seen by a provider with an ultrasound for confirmation of abortion completion. Participants who do not come for a return visit receive one phone call to reschedule their appointment.	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.
EXPERIMENTAL: Home follow-up group; Participants enrolled in the home follow-up group will be instructed that they will be contacted by research staff through text message 14 days after the initial visit. At enrollment, they will receive instruction for timing of contact, how to use the LSPT, as well as the test itself. The participant will take the pregnancy test at home in 14 days and answer completion questions by text message for follow-up. Patients that screen positive will be asked to return to clinic for a visit with a provider.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completed follow-up for the clinic group	Percent of participants in this group that return to the scheduled clinic visit	2 weeks
Completed follow-up for the home group	Percent of participants in this group that completed the final texted survey	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any follow up	Number of participants who had any follow-up based on unscheduled clinic visits	42 days
Ongoing pregnancy	Number of participants found to have an ongoing pregnancy after a medication abortion	42 days
Complications after the medical abortion	Number of participants presenting with complications such need for transfusion and treatment of a uterine infection	42 days
Number of emergency visits	Number of participants presenting to the emergency room	42 days
Acceptability of chosen follow-up	An investigator developed survey will document acceptability of the follow-up process, given at the follow-up visit	2 weeks
Screen positive for pregnancy in the home follow-up group	The percentage of participants that screen positive from a urine test using LSPT in the home follow-up group, requiring a clinic follow-up visit	2 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Cara Delaney, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (ACTUAL): March 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Text messaging; Home follow-up; Clinic follow-up; Low Sensitivity Pregnancy Test (LSPT); Medication abortion
• Other Study ID Numbers: H-39499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No