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

This study has been completed.
Sponsor:
Collaborator:
British Pregnancy Advisory Service (UK) (bpas)
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01362387
First received: May 2, 2011
Last updated: February 13, 2013
Last verified: May 2011
  Purpose

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

Condition Intervention
Legally Induced Abortion, Complete, Without Mention of Complication
Other: Alternative follow-up protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: R U OK? The Acceptability and Feasibility of New Communication Technologies for Follow-up After Medical Abortion

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Number of women with complete clinical information on post-abortion status [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 999
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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
Experimental: Group 2
Follow-up after medical abortion using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test.
Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362387

Locations
United Kingdom
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
Sponsors and Collaborators
Gynuity Health Projects
British Pregnancy Advisory Service (UK) (bpas)
Investigators
Principal Investigator: Hillary Bracken, PhD Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01362387     History of Changes
Other Study ID Numbers: 1.4.3
Study First Received: May 2, 2011
Last Updated: February 13, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Gynuity Health Projects:
Medical abortion
abortion follow-up

ClinicalTrials.gov processed this record on July 29, 2014