1-what do you think are the most appropriate quanti and quali study designs/methodologies to investigate the relation between caffeine exposure during pregnancy and births before 37-41 weeks of gestation ?
2-what are the ethical considerations to be taken into account during this study ?
"what are the ethical considerations to be taken into account during this study ?"
The most important ethical consideration is ensuring that all the previous epidemiological research has been personally read, performing a meta-analysis if not already done.
There is a relatively thorough systemic review in Leeds University in the UK, can serve as a good background start.
http://www.ncbi.nlm.nih.gov/pubmed/25179792
See our article in the European Journal of Public Health, Vol. 23, No. 3, 480–485
doi:10.1093/eurpub/cks089
Risk factors of preterm birth and low birth weight babies among Roma and non-Roma mothers: a population-based study.
In the multivariable logistic regression model (non concerning ethnic differences) the effect on PTB of non-daily versus daily consumption of caffein was: OR=0.97 95%CI=0.84–1.26 p=0.899.
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