Home Follow-up After Medication Abortion

NCT04304365 | Withdrawn

• 1 other identifier: H-39499
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Medical; Abortion, Fetus

Keywords

Home follow-up; Clinic follow-up; Low Sensitivity Pregnancy Test (LSPT); Text messaging; Medication abortion

Outcome Measures

Primary Outcomes (2)

• Completed follow-up for the clinic group

  Percent of participants in this group that return to the scheduled clinic visit

  2 weeks

• Completed follow-up for the home group

  Percent of participants in this group that completed the final texted survey

  2 weeks

Secondary Outcomes (6)

• Any follow up

  42 days

• Ongoing pregnancy

  42 days

• Complications after the medical abortion

  42 days

• Number of emergency visits

  42 days

• Acceptability of chosen follow-up

  2 weeks

Study Arms (2)

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.

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.

Other: Text message; Other: Low Sensitivity Pregnancy Test (LSPT)

Interventions

Follow-up clinic visit OTHER

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

Clinic follow-up group

Text message 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.

Home follow-up group

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.

Home follow-up group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boston Medical Center: lead
• Society of Family Planning: collaborator

Study Officials

• Cara Delaney, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share