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

Sponsor

Women's College Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01943279

Collaborator

(none)

139

Enrollment

Locations

Arms

Duration (Months)

69.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medical; Abortion, Fetus	Other: Remote Follow-up (RFU) Other: Standard Follow-up (SFU)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

139 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Rate of successful follow-up in women choosing RFU compared with those choosing SFU after medical abortion with M&M [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 Outcome Measures

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 Outcome Measures

Emergency department visit [Within 28 days of methotrexate injection ±3 days]
Determined through subject history
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]
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) [Within 35 days of methotrexate injection]
Infection requiring antibiotics [Within 28 days of methotrexate injection ±3 days]
Determined from the clinic record or subject history
Acceptability of SFU and RFU [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.
Number of subject-initiated telephone contacts during clinic hours [Within 28 days of methotrexate injection ±3 days]
Abstracted from the medical record
Number of subject-initiated telephone contacts to on-call physician [Within 28 days of methotrexate injection ±3 days]
Abstracted from the medical record
Number of clinic-initiated telephone contacts outside of the scheduled follow-up contact for the RFU group [Within 28 days of methotrexate injection ±3 days]
Abstracted from the medical record
Number of letters sent [Within 28 days of methotrexate injection ±3 days]
Abstracted from the medical record
Selected method of contraception [At 28 days after methotrexate injection ±3 days]
Reason for choice of follow-up method [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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