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Completed

NCT Number: NCT01943279

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

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.

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Key information

Conditions

Medical; Abortion, Fetus

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Choice in Health Clinic, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: telephone follow-up, serum hCG

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.

Other names: In-clinic visit, Ultrasound

Primary outcomes

  1. 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

    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 outcomes

  1. Percent of women who choose RFU

    Time frame: 1 day

  2. 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

  3. 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

Other outcomes

  1. Emergency department visit

    Time frame: Within 28 days of methotrexate injection ±3 days

    Determined through subject history

  2. 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

    Determined from patient history with retrieval of emergency department/hospital records or documented drop of 20 g.

  3. 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

  4. Infection requiring antibiotics

    Time frame: Within 28 days of methotrexate injection ±3 days

    Determined from the clinic record or subject history

  5. Acceptability of SFU and RFU

    Time frame: At 28 days after methotrexate injection ±3 days

    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.

  6. Number of subject-initiated telephone contacts during clinic hours

    Time frame: Within 28 days of methotrexate injection ±3 days

    Abstracted from the medical record

  7. Number of subject-initiated telephone contacts to on-call physician

    Time frame: Within 28 days of methotrexate injection ±3 days

    Abstracted from the medical record

  8. 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

    Abstracted from the medical record

  9. Number of letters sent

    Time frame: Within 28 days of methotrexate injection ±3 days

    Abstracted from the medical record

  10. Selected method of contraception

    Time frame: At 28 days after methotrexate injection ±3 days

  11. Reason for choice of follow-up method

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Official study title

A Comparison of Remote Follow-up After Medical Abortion Using Telephone and Serum Pregnancy Testing With Standard In-person Follow-up

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Sep 16, 2013
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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