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

Gynuity Health Projects

Status: Completed

Conditions: Legally Induced Abortion, Complete, Without Mention of Complication

Treatments: Other: Alternative follow-up protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01362387

1.4.3

Details and patient eligibility

About

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

Enrollment: 999 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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999 participants in 2 patient groups

Group 1

No Intervention group

Description:

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

Group 2

Experimental group

Description:

Follow-up after medical abortion using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test.

Treatment:

Other: Alternative follow-up protocol