Ethics

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The risks of participating in this study are very low. Additional blood and swabs are taken during pregnancy; however, these coincide with routine care and the risk of any adverse effect is minimal. Study participants may experience slight bleeding, pain/discomfort at the site of the needle insertion. An extra blood spot card will be taken from the infant while the routine blood spot is taken. Some of the items asked about in the questionnaires may cause some distress or make women feel uncomfortable. Study participants are free to refuse to answer any questions and encouraged to contact the study team at any time.

Throughout the course of the study some women undergo early pregnancy loss, stillbirth and other pregnancy complications. This is flagged in our records and we no longer contact them about this study if there has been a pregnancy loss. For women who are experiencing any distress, we find the appropriate resources, whether their own doctor, nurse or other health care professional, when these situations arise.

There is no direct benefit to the study participants. However, the study may give new knowledge that may help to provide invaluable insight into a wide range of pregnancy related diseases (e.g. pre-eclampsia, gestational diabetes, postpartum depression) that may ultimately improve the health of mother’s and infant’s while also improving the delivery of healthcare.

Study participants are recruited in an environment free of coercion, by trained staff that carefully explain the study and provide participants with time to consider and ask any questions. Study participation is voluntary and participants are able to refuse to participate in any aspect of the study or withdraw at any time.