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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sheila Dunn, Women's College Hospital
ClinicalTrials.gov Identifier:
NCT01943279
First received: September 11, 2013
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Medical; Abortion, Fetus
Other: Remote Follow-up (RFU)
Other: Standard Follow-up (SFU)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Comparison of Remote Follow-up After Medical Abortion Using Telephone and Serum Pregnancy Testing With Standard In-person Follow-up

Further study details as provided by Women's College Hospital:

Primary Outcome Measures:
  • Rate of successful follow-up in women choosing RFU compared with those choosing SFU after medical abortion with M&M [ Time Frame: Within the designated time of 15 days post methotrexate injection ±3 days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percent of women who choose RFU [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Percent of women choosing RFU who complete follow-up without a clinic visit [ Time Frame: Within the designated time of 15 days post methotrexate injection ±3 days ] [ Designated as safety issue: No ]
  • Percent of women in RFU and SFU groups who made no unscheduled visits related to medical abortion [ Time Frame: Within 28 days of methotrexate injection ±3 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Emergency department visit [ Time Frame: Within 28 days of methotrexate injection ±3 days ] [ Designated as safety issue: Yes ]
    Determined through subject history

  • Hemorrhage - defined as bleeding resulting in transfusion, intravenous fluids or a drop in hemoglobin of 20 g [ Time Frame: Within 28 days of methotrexate injection ±3 days ] [ Designated as safety issue: Yes ]
    Determined from patient history with retrieval of emergency department/hospital records or documented drop of 20 g.

  • 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) [ Time Frame: Within 35 days of methotrexate injection ] [ Designated as safety issue: No ]
  • Infection requiring antibiotics [ Time Frame: Within 28 days of methotrexate injection ±3 days ] [ Designated as safety issue: Yes ]
    Determined from the clinic record or subject history

  • Acceptability of SFU and RFU [ Time Frame: At 28 days after methotrexate injection ±3 days ] [ Designated as safety issue: No ]
    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.

  • Number of subject-initiated telephone contacts during clinic hours [ Time Frame: Within 28 days of methotrexate injection ±3 days ] [ Designated as safety issue: No ]
    Abstracted from the medical record

  • Number of subject-initiated telephone contacts to on-call physician [ Time Frame: Within 28 days of methotrexate injection ±3 days ] [ Designated as safety issue: No ]
    Abstracted from the medical record

  • Number of clinic-initiated telephone contacts outside of the scheduled follow-up contact for the RFU group [ Time Frame: Within 28 days of methotrexate injection ±3 days ] [ Designated as safety issue: No ]
    Abstracted from the medical record

  • Number of letters sent [ Time Frame: Within 28 days of methotrexate injection ±3 days ] [ Designated as safety issue: No ]
    Abstracted from the medical record

  • Selected method of contraception [ Time Frame: At 28 days after methotrexate injection ±3 days ] [ Designated as safety issue: No ]
  • Reason for choice of follow-up method [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: 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 Names:
  • In-clinic visit
  • Ultrasound
Experimental: 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.
Other: Remote Follow-up (RFU)
Women in the RFU group will be asked to return to the clinic for assessment if they have any complications.
Other Names:
  • telephone follow-up
  • serum hCG

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943279

Locations
Canada, Ontario
Women's College Hospital-Bay Center for Birth Control
Toronto, Ontario, Canada, M5G1N8
Choice in Health Clinic
Toronto, Ontario, Canada, M6P 1A9
Sponsors and Collaborators
Women's College Hospital
Investigators
Principal Investigator: Sheila Dunn, MD MSc CCFP Women's College Hospital, University of Toronto
  More Information

Publications:

Responsible Party: Sheila Dunn, MD, MSc, CCFP(EM), FCFP, Women's College Hospital
ClinicalTrials.gov Identifier: NCT01943279     History of Changes
Other Study ID Numbers: DUNNS-AFPFY112-RFUMA
Study First Received: September 11, 2013
Last Updated: September 20, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Women's College Hospital:
medical abortion
telephone follow-up
ultrasound
serum hCG
methotrexate
misoprostol

ClinicalTrials.gov processed this record on August 28, 2014