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

NCT01943279 | Completed

• 1 other identifier: DUNNS-AFPFY112-RFUMA
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Medical; Abortion, Fetus

Keywords

medical abortion; telephone follow-up; ultrasound; serum hCG; methotrexate; misoprostol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Other Outcomes (11)

• Emergency department visit

  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

  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

Study Arms (2)

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.

Other: Standard Follow-up (SFU)

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.

Other: Remote Follow-up (RFU)

Interventions

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.

Also known as: telephone follow-up, serum hCG

Remote Follow-up (RFU)

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.

Also known as: In-clinic visit, Ultrasound

Standard Follow-up (SFU)

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (2)

Women's College Hospital-Bay Center for Birth Control

Toronto, Ontario, M5G1N8, Canada

Location

Choice in Health Clinic

Toronto, Ontario, M6P 1A9, Canada

Location

Related Publications (9)

• 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.

  PMID: 20103453 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.

  PMID: 17241843 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.

  PMID: 20093898 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.

  PMID: 21310279 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.

  PMID: 12860340 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.

  PMID: 8773418 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.

  PMID: 14511962 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.

  PMID: 11704083 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.

  PMID: 15451336 BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Sheila Dunn, MD MSc CCFP

  Women's College Hospital, University of Toronto

  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: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, CCFP(EM), FCFP

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 16, 2013
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

CA (2)