Comparison of Telephone Follow-up With In-person Follow-up After Medical Abortion

Study Overview
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Brief Summary
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Background: Medical abortions in Canada are provided using a standard regimen of methotrexate and misoprostol. After these medications are administered, patients are most commonly checked for termination of the pregnancy with an ultrasound and physical examination at an in-clinic follow-up appointment. These follow-up appointments can be inconvenient, costly, and take away from patient privacy. Furthermore, it has been suggested that these follow-up appointments may not be necessary for patients. Objective: To determine whether remote follow-up, using telephone and blood testing is a feasible, safe, and effective method of follow-up after medical abortion, compared to standard care that requires an in-clinic visit and ultrasound. This study offers women the option of remote follow-up by telephone combined with serum Beta-human chorionic gonadotropin (β-hCG) testing or standard in-clinic follow up. We will determine women's preferences for follow up, and compare adherence to the follow-up schedule, number of clinical contacts, and outcomes of the abortion. This study will be performed at two clinics in Toronto, the Bay Centre for Birth Control (BCBC) and the Choice in Health Clinic (CIHC). Primary Hypothesis: Follow-up will be more successful with RFU, compared to SFU.

Detailed Description
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The protocol is altered for women who have an ultrasound that shows only a gestational sac (no yolk sac or fetal pole). Women in both follow-up groups will have β-hCG testing on the day of methotrexate injection and again in 8 days. If the level does not fall by 50% or they have concerning symptoms, they are asked to return to clinic for evaluation. If the β-hCG level falls by 50% or more, they will continue to be followed as per the protocol in their chosen group, but will be followed until their β-hCG becomes negative.

Official Title
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A Comparison of Remote Follow-up After Medical Abortion Using Telephone and Serum Pregnancy Testing With Standard In-person Follow-up

Conditions
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Medical; Abortion, Fetus

Intervention / Treatment
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* Other: Remote Follow-up (RFU)
* Other: Standard Follow-up (SFU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requests a medical abortion and fulfills standard eligibility criteria for M&M abortion: Clear decision to have an abortion Valid Ontario Health card Willing to abstain for vaginal intercourse and alcohol for 14 days Ability to insert misoprostol vaginal tablets Emergency Contact number Stop folic acid vitamins on initial contact Good general health Single intrauterine gestation less than or equal to 49 days as determined by transvaginal ultrasound Telephone access Access to emergency medical care within 30 minutes of home Agrees to undergo a surgical abortion in case of failure of the medical abortion method Ability to understand the protocol and consent Willingness to comply with either the SFU or RFU follow-up schedule Exclusion Criteria: Factors that exclude women from eligibility for M&M abortion: Coagulopathy or hemoglobin less than 100, White Blood Cell count < 4.0 platelet <140,000 Allergy to methotrexate or misoprostol Presence of an intrauterine device Acute or chronic renal or hepatic disease Acute inflammatory bowel disease Uncontrolled seizure disorder Sickle cell anemia Breastfeeding Chronic oral corticosteroid therapy Any condition that in the opinion of the clinician investigator would compromise the safety of medical abortion for this patient Requires the support of an interpreter

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Follow-up (SFU)<br>Women selecting SFU at either site (BCBC or CIHC) will schedule their in-person follow-up appointment before leaving the BCBC clinic on Study Day 1, when they receive their medication. In-person follow-up appointment will be scheduled for Study Day 15 (± 3 days)where, as per usual care, includes a history and a Post-abortion Checklist, transvaginal ultrasound, and a bimanual exam to confirm successful pregnancy expulsion. | Other: Standard Follow-up (SFU)<br>* Study Day 15 (± 3 days)requires an in-person post-abortion checkup: transvaginal ultrasound, and a bimanual exam to confirm successful pregnancy expulsion.<br>* Other names: Ultrasound;|
| Experimental: Remote Follow-up (RFU)<br>On Study Day 1 in both sites, women selecting RFU will receive 3 laboratory requisition forms for serum β-hCG testing and will be instructed to have testing done at a laboratory site of her choice on Study Day 10-12. The follow-up telephone appointment will be scheduled to take place on Study Day 15 (±3 days). For the follow-up telephone appointment, the research nurse/nurse practitioner will calculate the percentage fall in the β-hCG value. She will contact the subject by phone at the specified time, take a history of the timing of misoprostol use, resulting symptoms and complete the symptom Post-abortion Check-list. The research nurse/nurse practitioner, in consultation with the clinic physician if necessary, will confirm the information, determine whether other follow-up is required. | Other: Remote Follow-up (RFU)<br>* Women in the RFU group will be asked to return to the clinic for assessment if they have any complications.<br>* Other names: serum hCG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful follow-up in women choosing RFU compared with those choosing SFU after medical abortion with M&M | Successful follow-up will be defined as completion of telephone follow-up contact and serum β-hCG testing (for the RFU cohort) or attendance for the in-clinic follow-up visit within the designated time of 15 days post methotrexate injection ±3 days (for the SFU cohort). | Within the designated time of 15 days post methotrexate injection ±3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of women who choose RFU |  | 1 day | 
| Percent of women choosing RFU who complete follow-up without a clinic visit |  | Within the designated time of 15 days post methotrexate injection ±3 days | 
| Percent of women in RFU and SFU groups who made no unscheduled visits related to medical abortion |  | Within 28 days of methotrexate injection ±3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical abortion, telephone follow-up, ultrasound, serum hCG, methotrexate, misoprostol