Legally Induced Abortion, Complete, Without Mention of Complication
Conditions
Keywords
Medical abortion, abortion follow-up
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
Interventions
OTHERAlternative 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.
Sponsors
British Pregnancy Advisory Service
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed