Module232025

07/05/2025

Contacting the pregnant partner

The correct process looks like this:

• The male participant informs the centre that his partner is pregnant

• The centre provides the triallist with two documents: An information sheet which explains to rationale for collecting data from the partner quite different from the information provided to a female triallist does not need to describe the condition the trial is examining does need to explain what, if any, information will be shared with the triallist A release form, which the partner completes and signs, giving her contact details and permission to be contacted

• The triallist returns these documents to the centre

• The centre initiates contact with the partner

If the partner is a minor and not a triallist, data privacy regulations apply, and the minor may be able to authorise the sharing of information without parental consent – but seek legal advice Se also reference #15

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Detection of injury to the foetus and child

1. Antenatal tests First Trimester: Screening tests like nuchal translucency scans (between 11 and 14 weeks) and maternal blood tests can be used to assess the risk of certain chromosomal disorders like Down syndrome. Second Trimester: Anatomy scans (around 18-21 weeks) can help identify major structural birth defects. Other Tests: Amniocentesis (15-20 weeks) and chorionic villus sampling (10-12 weeks) can also provide information about genetic disorders. 2. Postnatal tests Newborn Screening: Blood tests are performed on newborns to detect certain genetic disorders. Physical Examinations can identify some birth defects, e.g., clubfoot, cleft palate. 3. Later detections hearing impairment – up to 6 months balance impairment (crawling, sitting unsupported) – 6-12 months mild generalised cognitive impairment - when the child starts attending school 4. DES – 12 years So, for how long should pregnancy exposures be tracked?

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