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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Follow-up (SFU) | Active Comparator | 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. |
|
| Remote Follow-up (RFU) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Follow-up (RFU) | Other | Women in the RFU group will be asked to return to the clinic for assessment if they have any complications. |
|
| 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 |
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency department visit | Determined through subject history | Within 28 days of methotrexate injection ±3 days |
| Hemorrhage - defined as bleeding resulting in transfusion, intravenous fluids or a drop in hemoglobin of 20 g |
Inclusion Criteria:
Requests a medical abortion and fulfills standard eligibility criteria for M&M abortion:
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:
Requires the support of an interpreter
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| Name | Affiliation | Role |
|---|---|---|
| Sheila Dunn, MD MSc CCFP | Women's College Hospital, University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital-Bay Center for Birth Control | Toronto | Ontario | M5G1N8 | Canada | ||
| Choice in Health Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20103453 | Background | Perriera LK, Reeves MF, Chen BA, Hohmann HL, Hayes J, Creinin MD. Feasibility of telephone follow-up after medical abortion. Contraception. 2010 Feb;81(2):143-9. doi: 10.1016/j.contraception.2009.08.008. Epub 2009 Sep 30. | |
| 17241843 | Background | Clark W, Panton T, Hann L, Gold M. Medication abortion employing routine sequential measurements of serum hCG and sonography only when indicated. Contraception. 2007 Feb;75(2):131-5. doi: 10.1016/j.contraception.2006.08.001. Epub 2006 Dec 22. |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Standard Follow-up (SFU) | Other | Study Day 15 (± 3 days)requires an in-person post-abortion checkup: transvaginal ultrasound, and a bimanual exam to confirm successful pregnancy expulsion. |
|
|
| 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 |
Determined from patient history with retrieval of emergency department/hospital records or documented drop of 20 g.
| Within 28 days of methotrexate injection ±3 days |
| D&C with the cause characterized as 1) for bleeding, at clinician's recommendation, 2) for continuing pregnancy, 3) at patient's request (usually because of delayed expulsion of the pregnancy in a medically stable patient) | Within 35 days of methotrexate injection |
| Infection requiring antibiotics | Determined from the clinic record or subject history | Within 28 days of methotrexate injection ±3 days |
| Acceptability of SFU and RFU | Measured using an Acceptability Questionnaire administered at discharge from ongoing care. This questionnaire is adapted from a previous study of acceptability of mifepristone and misoprostol abortions by Winikoff et al. It contains four close-ended and three open-ended questions designed to capture the patient's perspective on their medical abortion experience, whether they would choose the same method of follow-up in future, and their opinions on the best and worst features of their chosen follow-up method. | At 28 days after methotrexate injection ±3 days |
| Number of subject-initiated telephone contacts during clinic hours | Abstracted from the medical record | Within 28 days of methotrexate injection ±3 days |
| Number of subject-initiated telephone contacts to on-call physician | Abstracted from the medical record | Within 28 days of methotrexate injection ±3 days |
| Number of clinic-initiated telephone contacts outside of the scheduled follow-up contact for the RFU group | Abstracted from the medical record | Within 28 days of methotrexate injection ±3 days |
| Number of letters sent | Abstracted from the medical record | Within 28 days of methotrexate injection ±3 days |
| Selected method of contraception | At 28 days after methotrexate injection ±3 days |
| Reason for choice of follow-up method | 1 day |
| Toronto |
| Ontario |
| M6P 1A9 |
| Canada |
| 20093898 | Background | Clark W, Bracken H, Tanenhaus J, Schweikert S, Lichtenberg ES, Winikoff B. Alternatives to a routine follow-up visit for early medical abortion. Obstet Gynecol. 2010 Feb;115(2 Pt 1):264-272. doi: 10.1097/AOG.0b013e3181c996f3. |
| 21310279 | Background | Kaneshiro B, Edelman A, Sneeringer RK, Ponce de Leon RG. Expanding medical abortion: can medical abortion be effectively provided without the routine use of ultrasound? Contraception. 2011 Mar;83(3):194-201. doi: 10.1016/j.contraception.2010.07.023. Epub 2010 Sep 17. |
| 12860340 | Background | Fiala C, Safar P, Bygdeman M, Gemzell-Danielsson K. Verifying the effectiveness of medical abortion; ultrasound versus hCG testing. Eur J Obstet Gynecol Reprod Biol. 2003 Aug 15;109(2):190-5. doi: 10.1016/s0301-2115(03)00012-5. |
| 8773418 | Background | Creinin MD, Vittinghoff E, Keder L, Darney PD, Tiller G. Methotrexate and misoprostol for early abortion: a multicenter trial. I. Safety and efficacy. Contraception. 1996 Jun;53(6):321-7. doi: 10.1016/0010-7824(96)00080-7. |
| 14511962 | Background | von Hertzen H, Honkanen H, Piaggio G, Bartfai G, Erdenetungalag R, Gemzell-Danielsson K, Gopalan S, Horga M, Jerve F, Mittal S, Ngoc NT, Peregoudov A, Prasad RN, Pretnar-Darovec A, Shah RS, Song S, Tang OS, Wu SC; WHO Research Group on Post-Ovulatory Methods for Fertility Regulation. WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. I: Efficacy. BJOG. 2003 Sep;110(9):808-18. doi: 10.1111/j.1471-0528.2003.02430.x. |
| 11704083 | Background | Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Contraception. 2001 Aug;64(2):81-5. doi: 10.1016/s0010-7824(01)00229-3. |
| 15451336 | Background | Rossi B, Creinin MD, Meyn LA. Ability of the clinician and patient to predict the outcome of mifepristone and misoprostol medical abortion. Contraception. 2004 Oct;70(4):313-7. doi: 10.1016/j.contraception.2004.04.005. |
| D055585 |
| Physical Phenomena |