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Completed

NCT Number: NCT01362387

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

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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Key information

Conditions

Legally Induced Abortion, Complete, Without Mention of Complication

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Day Care Unit, Birmingham, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alternative follow-up protocol

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • British Pregnancy Advisory Service

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 30, 2011
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.