Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT05461950
Eligibility Criteria:
Inclusion Criteria:
* live infants (singletons or dichorionic twins) born in gestational week 32+0 to 42+0
* delivered by CS in regional anaesthesia
* immediate care may be planned with involved personnel prior to delivery
* informed maternal consent is obtained (parental consent on behalf of the unborn child).
Exclusion Criteria:
* twins, triplets
* significant congenital malformations
* placenta complications with high risk of abnormal maternal blood loss
* severe fetal distress requiring cesarean section in general anaesthesia (crash CS)
* participation in any other clinical study within the last month
* not sufficient time for preparations or collection of maternal/parental consent
* mother does not comprehend Norwegian or English
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
32 Weeks
Maximum Age:
42 Weeks
Study:
NCT05461950
Study Brief:
Protocol Section:
NCT05461950