Comparison of Telephone Follow-up With In-person Follow-up After Medical Abortion
NCT ID: NCT01943279
Last Updated: 2014-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2011-07-31
2014-12-31
Brief Summary
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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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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard Follow-up (SFU)
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.
Standard Follow-up (SFU)
Study Day 15 (± 3 days)requires an in-person post-abortion checkup: transvaginal ultrasound, and a bimanual exam to confirm successful pregnancy expulsion.
Remote Follow-up (RFU)
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.
Remote Follow-up (RFU)
Women in the RFU group will be asked to return to the clinic for assessment if they have any complications.
Interventions
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Remote Follow-up (RFU)
Women in the RFU group will be asked to return to the clinic for assessment if they have any complications.
Standard Follow-up (SFU)
Study Day 15 (± 3 days)requires an in-person post-abortion checkup: transvaginal ultrasound, and a bimanual exam to confirm successful pregnancy expulsion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
2. Ability to understand the protocol and consent
3. Willingness to comply with either the SFU or RFU follow-up schedule
Exclusion Criteria
* 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
2. Requires the support of an interpreter
16 Years
FEMALE
No
Sponsors
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Women's College Hospital
OTHER
Responsible Party
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Sheila Dunn
MD, MSc, CCFP(EM), FCFP
Principal Investigators
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Sheila Dunn, MD MSc CCFP
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital, University of Toronto
Locations
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Women's College Hospital-Bay Center for Birth Control
Toronto, Ontario, Canada
Choice in Health Clinic
Toronto, Ontario, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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DUNNS-AFPFY112-RFUMA
Identifier Type: -
Identifier Source: org_study_id