Medical; Abortion, FetusNCT04304365
Home Follow-up After Medication Abortion
A study testing Follow-up clinic visit, Text message and Low Sensitivity Pregnancy Test (LSPT) in people with Medical; Abortion, Fetus, run by Boston Medical Center.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Medical; Abortion, Fetus
- What is being tested?
- Follow-up clinic visit, Text message and Low Sensitivity Pregnancy Test (LSPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -None
About this study
Official title: 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.
Read the 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
- Being tested
- Follow-up clinic visit, Text message, Low Sensitivity Pregnancy Test (LSPT)
- Keywords
- Home follow-up, Clinic follow-up, Low Sensitivity Pregnancy Test (LSPT), Text messaging, Medication abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up clinic visitOther
Participants will be scheduled for a visit with a provider in 1-2 weeks that will include an ultrasound examination.
Text messageOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Clinic follow-up group | Active comparator | 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. Receives: Other: Follow-up clinic visit |
| Home follow-up group | Experimental | 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. Receives: Other: Text message; Other: Low Sensitivity Pregnancy Test (LSPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completed follow-up for the clinic group
Percent of participants in this group that return to the scheduled clinic visit
Measured: 2 weeks
Completed follow-up for the home group
Percent of participants in this group that completed the final texted survey
Measured: 2 weeks
Secondary outcomes (6)
Any follow up
Number of participants who had any follow-up based on unscheduled clinic visits
Measured: 42 days
Ongoing pregnancy
Number of participants found to have an ongoing pregnancy after a medication abortion
Measured: 42 days
Complications after the medical abortion
Number of participants presenting with complications such need for transfusion and treatment of a uterine infection
Measured: 42 days
Number of emergency visits
Number of participants presenting to the emergency room
Measured: 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
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study startOct 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Unable to implement the study due to delays from COVID-19 policies which postponed the start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical; Abortion, FetusStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Cara Delaney, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304365
- Sponsor's protocol ID
- H-39499
- Status last verified
- Oct 2020
- First submitted
- 9 Mar 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home Follow-up After Medication Abortion (MAB)
- ClinicalTrials.gov ID
- NCT04304365
- Acronym / sponsor ID
- H-39499
- Conditions
- Medical; Abortion, Fetus
- Keywords
- Home follow-up, Clinic follow-up, Low Sensitivity Pregnancy Test (LSPT), Text messaging, Medication abortion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to implement the study due to delays from COVID-19 policies which postponed the start.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Oct 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic follow-up group | Active comparator | Other: Follow-up clinic visitAll 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. |
| Home follow-up group | Experimental | Other: Text message, Other: Low Sensitivity Pregnancy Test (LSPT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up clinic visitParticipants will be scheduled for a visit with a provider in 1-2 weeks that will include an ultrasound examination. | Other | Clinic follow-up group |
| Text messageParticipants 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 | Home follow-up group |
| 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. | Other | Home follow-up group |
Primary outcome
Completed follow-up for the clinic group
Time frame: 2 weeks
Percent of participants in this group that return to the scheduled clinic visit
Completed follow-up for the home group
Time frame: 2 weeks
Percent of participants in this group that completed the final texted survey
6 secondary outcomes
Any follow up
Time frame: 42 days
Ongoing pregnancy
Time frame: 42 days
Complications after the medical abortion
Time frame: 42 days
Number of emergency visits
Time frame: 42 days
Acceptability of chosen follow-up
Time frame: 2 weeks
Screen positive for pregnancy in the home follow-up group
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara Delaney, MD principal investigator
Boston Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up clinic visit, Text message and Low Sensitivity Pregnancy Test (LSPT) in people with Medical; Abortion, Fetus, run by Boston Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completed follow-up for the clinic group (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.