CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 139 enrolled
Drug / intervention
Remote Follow-up (RFU) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01943279
NCT01943279N/ACompleted

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

Women's College Hospital·interventional·Posted Sep 16, 2013·Updated Dec 10, 2014

In Brief

A clinical study evaluating Remote Follow-up (RFU) and Standard Follow-up (SFU) for Medical; Abortion, Fetus. Completed, enrolled 139 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2013
Enrollment StartJul 1, 2011
Primary CompletionJul 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.8 years ago

Interventions

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.

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.