Clinical trial NCT01943279: Comparison of Telephone Follow-up With In-person Follow-up After Medical Abortion
Official title: A Comparison of Remote Follow-up After Medical Abortion Using Telephone and Serum Pregnancy Testing With Standard In-person Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical; Abortion, Fetus
Keywords: medical abortion
telephone follow-up
ultrasound
serum hCG
methotrexate
misoprostol
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 139
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Ability to understand the protocol and consent
3. Willingness to comply with either the SFU or RFU follow-up schedule

Exclusion Criteria:

1. 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
2. Requires the support of an interpreter

Primary outcomes:
measure: Rate of successful follow-up in women choosing RFU compared with those choosing SFU after medical abortion with M&M
timeFrame: Within the designated time of 15 days post methotrexate injection ±3 days
Secondary outcomes:
measure: Percent of women who choose RFU
timeFrame: 1 day
measure: Percent of women choosing RFU who complete follow-up without a clinic visit
timeFrame: Within the designated time of 15 days post methotrexate injection ±3 days
measure: Percent of women in RFU and SFU groups who made no unscheduled visits related to medical abortion
timeFrame: Within 28 days of methotrexate injection ±3 days
Other outcomes:
measure: Emergency department visit
timeFrame: Within 28 days of methotrexate injection ±3 days
measure: Hemorrhage - defined as bleeding resulting in transfusion, intravenous fluids or a drop in hemoglobin of 20 g
timeFrame: Within 28 days of methotrexate injection ±3 days
measure: 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)
timeFrame: Within 35 days of methotrexate injection
measure: Infection requiring antibiotics
timeFrame: Within 28 days of methotrexate injection ±3 days
measure: Acceptability of SFU and RFU
timeFrame: At 28 days after methotrexate injection ±3 days
measure: Number of subject-initiated telephone contacts during clinic hours
timeFrame: Within 28 days of methotrexate injection ±3 days
measure: Number of subject-initiated telephone contacts to on-call physician
timeFrame: Within 28 days of methotrexate injection ±3 days
measure: Number of clinic-initiated telephone contacts outside of the scheduled follow-up contact for the RFU group
timeFrame: Within 28 days of methotrexate injection ±3 days
measure: Number of letters sent
timeFrame: Within 28 days of methotrexate injection ±3 days
measure: Selected method of contraception
timeFrame: At 28 days after methotrexate injection ±3 days
measure: Reason for choice of follow-up method
timeFrame: 1 day
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital-Bay Center for Birth Control
state: Ontario
city: Toronto
country: Canada
facility: Choice in Health Clinic
state: Ontario
Study officials:
affiliation: Women's College Hospital, University of Toronto
name: Sheila Dunn, MD MSc CCFP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
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