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

NCT01362387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 999

Last updated 2013-02-15

No results posted yet for this study

Summary

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

Conditions

  • Legally Induced Abortion, Complete, Without Mention of Complication

Interventions

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.

Sponsors & Collaborators

  • British Pregnancy Advisory Service

    collaborator OTHER
  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Hillary Bracken, PhD · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362387 on ClinicalTrials.gov