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Multiple births will be randomised individually.
A random effect to account for clustering of babies from multiple births will be included.
Occasionally stillborn siblings, often in triplets or other larger multiple births, will be unsexed.
Sensitivity of the effect estimates to adjustments for potential clustering of multiple births will also be examined.
Multiple births will be assigned to the same group (as the unit of randomisation is the family).
With regard to the analysis of child outcomes, multiple births will be treated as independent events in the primary analysis, in order that relative risks may be presented.
Similar(53)
As the neonatal morbidity and mortality is likely to depend on the number of multiple births, we will perform sensitivity analyses in which we will vary the number of multiple pregnancies in the IUI-COH strategy.
For multiple births outcome will be taken as the worst for any of the children.
Multiple birth status will be examined as the widely held view that singletons experience better outcomes than multiples has recently been challenged.
Multiple birth infants will be randomized independently, unless the parents or caregivers explicitly request that the siblings are allocated to the same treatment arm.
In the case of multiple births, each infant will be individually randomised.
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