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

Gynuity Health Projects999 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

999

Conditions

Legally Induced Abortion, Complete, Without Mention of Complication

Interventions

Alternative follow-up protocolOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

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.

Time frame: 14 days