The MyTIME clinical trial
Curtin UniversityDataset 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).Subjects
FOS:Medical and health sciences |Identifiers
Source Study
Trial name (public)
Melatonin supplementation effect on the Induction of labour rates in first-time MothErs: The MyTIME TrialTrial acronym
MyTIME
Trial ID
ACTRN12623000502639
Purpose
Treatment
Phase
Phase 3
Funding
Government body,NHMRC
Scientific enquiries
Dr Zoe Bradfield
Brief Summary
Problem: In the last 10 years, rates of induction of labour amongst first-time (nulliparous) mothers have increased by 43%, from 32% to 46%. Situated in the context of soaring medical costs, few significant improvements in perinatal outcomes have been realised in the last decade. Despite escalated investment and medical intervention, rates of stillbirths, neonatal deaths and maternal mortality remain largely unchanged. Conversely, rates of maternal and neonatal morbidity have increased, with ris .... Read more
Key Inclusion Criteria
Nulliparous women aged 16 years and over, with a singleton pregnancy in cephalic presentation, without clinical indication for induction, awaiting spontaneous onset of labour, not planning a scheduled birth before 41 weeks unless indicated and able to provide written informed consent to participate in the clinical trial.
Key Exclusion Criteria
Women with indications for induction of labour or caesarean section prior to 41 weeks because of medical complications; any fetal congenital abnormality or known fetal compromise that would necessitate admission to NICU after birth; any known sensitivity or adverse reaction to melatonin.
Can healthy volunteers participate?
No
Population
Sample Size 530
Min. age 16 Years
Max. age No limit
Sex Females
Condition category Induction of labour
Condition code Reproductive Health and Childbirth
Intervention
Intervention code Treatment: Drugs
The intervention for this trial is 3mg oral melatonin encapsulated tablet. Study participants will be dispensed the trial intervention (3mg oral melatonin encapsulated tablet) tablet. On the first evening of gestation week 39, women will take their first tablet. Participants will be advised to take the trial medication at 2000hrs each evening as this is a time of onset of (relative) darkness coincidental to the natural rise in circulating melatonin levels. Night-time administration will continue .... Read more
Comparison
Control group Placebo
The control for this trial is oral placebo tablet (microcellulose capsule) identical in appearance to the intervention. Study participants will be dispensed the trial placebo tablets. On the first evening of gestation week 39, women will take their first tablet. Participants will be advised to take the trial medication at 2000hrs each evening as this is a time of onset of (relative) darkness coincidental to the natural rise in circulating melatonin levels. Night-time administration of placebo wi .... Read more
Outcomes
Outcome: Induction of labour extracted from mandatory notification system/ perinatal database. Timepoint: At any time post-enrolment
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
1) analysed, aggregated data following the conclusion of the trial 2) de-identified participant data
When will data be available?
We anticipate data will be available from 2028 onwards and for up to 5 years after publication.
Available to whom?
1) individuals who read the publications arising from this study which will report de-identified, analysed and aggregated data 2) editors and peer reviewers of the final manuscript 3) interested relevant parties who contact the corresponding author requesting information about the trial and associated data
Available for what types of analyses?
1) Associated documents such as protocol, PI&CF may be available to relevant parties who request access by contacting the PI 2) The de-identified raw participant data may be made available to relevant, interested parties for future use, for example for inclusion in meta-analysis or for the planning of future trials/research studies.