The MyTIME clinical trial

Full description

Allocation to intervention: Randomised controlled trial Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Allocation will occur by central randomisation by phone or computer Methods used to generate the sequence in which subjects will be randomised (sequence generation) : Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) Masking / blinding: Blinded (masking used) Who is / are masked / blinded?: The people receiving the treatment/s Phase: Phase 3 Type of endpoint/s Efficacy Statistical methods / analysis Sample Size: Primary Outcome - Induction of Labour: Within the study site, the induction of labour rate for nulliparous women is 43%. Should antenatal melatonin be effective, we propose that a clinically relevant impact would see an overall decrease in the rate of inductions by 30%, from 43% down to 30%. Total sample size of 530 women (~265 per group) will attain 80% power to detect this clinically relevant reduction of induction rate in the melatonin group (odds ratio of 0.57) while using logistic regression analysis with adjustment for the stratification factors and other relevant covariates with an r-squared of 0.025 at alpha=0.025. This sample size is also inflated for account for a 10% loss to follow-up (Power and Sample Size Program for Windows, version 2019) and to allow for a single interim analysis. Power >80% will also be achieved for all continuous secondary outcomes and for most categorical secondary outcomes, except for the low incidence secondary outcomes ie APGAR at 5 mins. Statistical Analysis Data will be analysed on intention-to-treat basis. Logistic and binomial regression analyses will be performed on primary endpoint and other binary outcomes. Linear and/or Cox proportional hazards regression will be used to examine group differences between the continuous and time to event outcomes. Melatonin adherence will be assessed and, if applicable, supplementary analyses on the adherent subgroup and per treatment received will also be performed. All hypothesis tests will be two-sided with alpha=0.05. Data analyses will be performed using STATA statistical software (version 16).

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