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:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT04394533
Eligibility Criteria:
Inclusion Criteria:
* Healthy (ASA score 2 or 3) pregnant women presenting for elective cervical cerclage under SAB.
* Age \> 18 years
Exclusion Criteria:
* Inability to read or understand the patient information sheet (PIS)
* Age \< 18 years
* Unable or unwilling to consent to participation
* non-elective procedure
* serious co-morbidities (ASA score 4 or above)
* any contraindication to SAB, e.g. local or generalised infection, active central nervous system disease, coagulation disorders or anti-coagulant medication
* any history of allergic reaction to any of the medications in the protocol
* concomitant use of class III anti-arrhythmics (sulfonamides, antimalarials, sodium nitroprussate, nitroglycerin, other local anaesthetics)
* any contraindication to the use of bupivacaine or prilocaine as listed in the SmPCs.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04394533
Study Brief:
Protocol Section:
NCT04394533