Home Follow-up After Medication Abortion

NCT ID: NCT04304365

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2021-05-31

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.

Conditions

Medical; Abortion, Fetus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Follow-up clinic visit

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Text message

Intervention Type: OTHER

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.

Low Sensitivity Pregnancy Test (LSPT)

Intervention Type: OTHER

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.

Interventions

Follow-up clinic visit

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cara Delaney, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Other Identifiers

H-39499

Identifier Type: -

Identifier Source: org_study_id