Smith, Chris; Ngo, Thoai D; Edwards, Phil; Free, Caroline; (2014) MObile Technology for Improved Family Planning: update to randomised controlled trial protocol. Trials, 15 (1). 440-. ISSN 1745-6215 DOI: https://doi.org/10.1186/1745-6215-15-440
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Abstract
BACKGROUND: This update outlines changes to the MObile Technology for Improved Family Planning study statistical analysis plan and plans for long-term follow-up. These changes result from obtaining additional funding and the decision to restrict the primary analysis to participants with available follow-up data. The changes were agreed prior to finalising the statistical analysis plan and sealing the dataset. METHODS/DESIGN: The primary analysis will now be restricted to subjects with data on the primary outcome at 4-month follow-up. The extreme-case scenario, where all those lost to follow-up are counted as non-adherent, will be used in a sensitivity analysis. In addition to the secondary outcomes outlined in the protocol, we will assess the effect of the intervention on long-acting contraception (implant, intra-uterine device and permanent methods).To assess the long-term effect of the intervention, we plan to conduct additional 12-month follow-up by telephone self-report for all the primary and secondary outcomes used at 4 months. All participants provided informed consent for this additional follow-up when recruited to the trial. Outcome measures and analysis at 12 months will be similar to those at the 4-month follow-up. The primary outcomes of the trial will be the use of an effective modern contraceptive method at 4 months and at 12 months post-abortion. Secondary outcomes will include long-acting contraception use, self-reported pregnancy, repeat abortion and contraception use over the 12-month post-abortion period. DISCUSSION: Restricting the primary analysis to those with follow-up data is the standard approach for trial analysis and will facilitate comparison with other trials of interventions designed to increase contraception uptake or use. Undertaking 12-month trial follow-up will allow us to evaluate the long-term effect of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT01823861.
Item Type | Article |
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Faculty and Department |
Faculty of Infectious and Tropical Diseases > Dept of Clinical Research Faculty of Epidemiology and Population Health > Dept of Population Health (2012- ) Faculty of Epidemiology and Population Health > Dept of Medical Statistics |
PubMed ID | 25388660 |
ISI | 345128800001 |
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