NCT01943279

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Women's College Hospital · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Medical; Abortion, Fetus

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-07-01
• Completion: 2014-12-01
• First posted: 2013-09-16
• Last updated: 2014-12-10

Locations

2 sites across 1 country: Canada