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 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT02201095
Eligibility Criteria:
Inclusion Criteria:
* Patients with a singleton, uncomplicated pregnancy, presenting for elective caesarean section under spinal anaesthesia, where surgery and anaesthesia are expected to be uncomplicated. Patients scheduled for tubal ligation surgery (sterilisation) as part of the caesarean section may also be included.
Exclusion Criteria:
* Age under 18
* BMI \<19 or \>30
* Diseases of pregnancy: e.g. pregnancy induced hypertension
* Grand Multiparity - ie parity of 5 or greater
* Pre-operative pyrexia (temperature of 37.5 degrees C or greater)
* Pre-operative hypothermia (temperature 36.0 degrees or cooler)
* Significant co-existing maternal disease - e.g. congenital heart disease
* Co-existing maternal disease that could impact on temperature- e.g. hypo/hyperthyroid
* Coagulation abnormalities or anticipated excessive blood loss including any form of abnormal placentation
* Surgical procedure expected not to be routine/deviation from normal practice
* Condition preventing full, informed consent.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02201095
Study Brief:
Protocol Section:
NCT02201095