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Home Follow-up After Medication Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304365
Recruitment Status : Withdrawn (Unable to implement the study due to delays from COVID-19 policies which postponed the start.)
First Posted : March 11, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Medical; Abortion, Fetus Other: Follow-up clinic visit Other: Text message Other: Low Sensitivity Pregnancy Test (LSPT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feasibility of Home Follow-up After Medication Abortion (MAB)
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

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.




Primary Outcome Measures :
  1. Completed follow-up for the clinic group [ Time Frame: 2 weeks ]
    Percent of participants in this group that return to the scheduled clinic visit

  2. Completed follow-up for the home group [ Time Frame: 2 weeks ]
    Percent of participants in this group that completed the final texted survey


Secondary Outcome Measures :
  1. Any follow up [ Time Frame: 42 days ]
    Number of participants who had any follow-up based on unscheduled clinic visits

  2. Ongoing pregnancy [ Time Frame: 42 days ]
    Number of participants found to have an ongoing pregnancy after a medication abortion

  3. Complications after the medical abortion [ Time Frame: 42 days ]
    Number of participants presenting with complications such need for transfusion and treatment of a uterine infection

  4. Number of emergency visits [ Time Frame: 42 days ]
    Number of participants presenting to the emergency room

  5. Acceptability of chosen follow-up [ Time Frame: 2 weeks ]
    An investigator developed survey will document acceptability of the follow-up process, given at the follow-up visit

  6. Screen positive for pregnancy in the home follow-up group [ Time Frame: 2 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304365


Sponsors and Collaborators
Boston Medical Center
Society of Family Planning
Investigators
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Principal Investigator: Cara Delaney, MD Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT04304365    
Other Study ID Numbers: H-39499
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Home follow-up
Clinic follow-up
Low Sensitivity Pregnancy Test (LSPT)
Text messaging
Medication abortion