Home Follow-up After Medication Abortion

Medical; Abortion, Fetus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04304365
• Other study ID #: H-39499
• Status: Withdrawn
• Phase: N/A
• Start date: October 2020
• Est. completion date: May 2021

Study information

• Verified date: October 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medical; Abortion, Fetus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Society of Family Planning

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completed follow-up for the clinic group	Percent of participants in this group that return to the scheduled clinic visit	2 weeks
Primary	Completed follow-up for the home group	Percent of participants in this group that completed the final texted survey	2 weeks
Secondary	Any follow up	Number of participants who had any follow-up based on unscheduled clinic visits	42 days
Secondary	Ongoing pregnancy	Number of participants found to have an ongoing pregnancy after a medication abortion	42 days
Secondary	Complications after the medical abortion	Number of participants presenting with complications such need for transfusion and treatment of a uterine infection	42 days
Secondary	Number of emergency visits	Number of participants presenting to the emergency room	42 days
Secondary	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
Secondary	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