Medical; Abortion, Fetus
Conditions
Keywords
Home follow-up, Clinic follow-up, Low Sensitivity Pregnancy Test (LSPT), Text messaging, Medication abortion
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.
Interventions
OTHERFollow-up clinic visit
Participants will be scheduled for a visit with a provider in 1-2 weeks that will include an ultrasound examination.
OTHERText 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.
OTHERLow 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.
Sponsors
Society of Family Planning
Boston Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completed follow-up for the clinic group | 2 weeks | Percent of participants in this group that return to the scheduled clinic visit |
| Completed follow-up for the home group | 2 weeks | Percent of participants in this group that completed the final texted survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications after the medical abortion | 42 days | Number of participants presenting with complications such need for transfusion and treatment of a uterine infection |
| Number of emergency visits | 42 days | Number of participants presenting to the emergency room |
| Any follow up | 42 days | Number of participants who had any follow-up based on unscheduled clinic visits |
| Screen positive for pregnancy in the home follow-up group | 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 |
| Acceptability of chosen follow-up | 2 weeks | An investigator developed survey will document acceptability of the follow-up process, given at the follow-up visit |
| Ongoing pregnancy | 42 days | Number of participants found to have an ongoing pregnancy after a medication abortion |
Outcome results
None listed