Clinical trial NCT04304365: Home Follow-up After Medication Abortion
Official title: Feasibility of Home Follow-up After Medication Abortion (MAB)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Medical; Abortion, Fetus
Keywords: Home follow-up
Clinic follow-up
Low Sensitivity Pregnancy Test (LSPT)
Text messaging
Medication abortion
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2020-03-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completed follow-up for the clinic group
timeFrame: 2 weeks
measure: Completed follow-up for the home group
timeFrame: 2 weeks
Secondary outcomes:
measure: Any follow up
timeFrame: 42 days
measure: Ongoing pregnancy
timeFrame: 42 days
measure: Complications after the medical abortion
timeFrame: 42 days
measure: Number of emergency visits
timeFrame: 42 days
measure: Acceptability of chosen follow-up
timeFrame: 2 weeks
measure: Screen positive for pregnancy in the home follow-up group
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center
name: Cara Delaney, MD
role: PRINCIPAL_INVESTIGATOR
References: