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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

999 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-12-31

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

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Detailed Description

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Conditions

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Legally Induced Abortion, Complete, Without Mention of Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

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

Group Type EXPERIMENTAL

Alternative follow-up protocol

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes