R U OK? The Acceptability and Feasibility of New Communication Technologies for Follow-up After Medical Abortion

Not Applicable

Completed

• Conditions: Legally Induced Abortion, Complete, Without Mention of Complication
• Interventions: Other: Alternative follow-up protocol

• Registration Number: NCT01362387
• Lead Sponsor: Gynuity Health Projects

Brief Summary

Purpose: This randomised trial will compare outcomes and acceptability of an alternative medical abortion follow-up protocol using standardised text messaging, on-line questionnaire, or a phone interview and a low sensitivity pregnancy test with the current standard of care which consists of either a clinic visit and ultrasound scan or a telephone call and high sensitivity pregnancy test.

Hypothesis: The use of "alternative" methods to assess outcomes after early medical abortion will achieve a higher rate of follow-up than women undergoing "standard" follow-up

Primary aim: To determine the follow-up rate after early medical abortion with an alternative protocol as compared to a standard follow-up protocol

Secondary aims:

* To assess complication rates and receipt of further treatment among women in the two study arms

* To ascertain women's preferences for mode of communication regarding their post-medical abortion status

* To determine provider opinions and preferences for different follow-up modalities

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Status Verified: 2011-05
• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-05-30
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 999

Inclusion Criteria

• 16 years of age or older,
• eligible for an abortion under the terms of the Abortion Act (1967),
• requesting an early medical abortion,
• willing and able to comply with the study protocol and visit schedule,
• access to either a mobile phone, intranet or telephone and willing to have communication by one of these means to assess post-medical abortion status,
• willing to have call back messages left,
• willing and able to provide valid informed consent, and
• able to communicate in English.

Exclusion Criteria

• prior participation in this research study, or
• current participation in another research study that, in the opinion of the investigator, would interfere with the conduct of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2	Alternative follow-up protocol	Follow-up after medical abortion using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test.

Primary Outcome Measures

Name	Time	Method
Number of women with complete clinical information on post-abortion status	14 days	The primary purpose of this trial is to compare the ability of the two systems to identify the number of women who require additional medical abortion-related care.

Trial Locations

Locations (4)

Chester Day Care Unit; 🇬🇧 Chester, United Kingdom

Birmingham Day Care Unit; 🇬🇧 Birmingham, United Kingdom

Luton Day Care Unit; 🇬🇧 Luton, United Kingdom

London Central Day Care Unit; 🇬🇧 London, United Kingdom