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

Study Overview
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Brief Summary
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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

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

Conditions
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Legally Induced Abortion, Complete, Without Mention of Complication

Intervention / Treatment
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* Other: Alternative follow-up protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>Women assigned to Group 1 will receive the standard post-abortion follow-up currently used at bpas and will be undertaken as usual by staff at the treating clinic | |
| Experimental: Group 2<br>Follow-up after medical abortion using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test. | Other: Alternative follow-up protocol<br>* Women (n=1000) will be allocated by chance to one of two groups: alternative follow-up using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test, or standard follow-up which consists of an in person visit with an ultrasound or a telephone call and high sensitivity pregnancy test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women with complete clinical information on post-abortion status | 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. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical abortion, abortion follow-up