R U OK? The Acceptability and Feasibility of New Communication Technologies for Follow-up After Medical Abortion
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
- 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
|Legally Induced Abortion, Complete, Without Mention of Complication||Other: Alternative follow-up protocol|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Official Title:||R U OK? The Acceptability and Feasibility of New Communication Technologies for Follow-up After Medical Abortion|
- Number of women with complete clinical information on post-abortion status [ Time Frame: 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.
|Study Start Date:||April 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
No Intervention: Group 1
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
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362387
|Birmingham Day Care Unit|
|Birmingham, United Kingdom|
|Chester Day Care Unit|
|Chester, United Kingdom|
|London Central Day Care Unit|
|London, United Kingdom|
|Luton Day Care Unit|
|Luton, United Kingdom|
|Principal Investigator:||Hillary Bracken, PhD||Gynuity Health Projects|