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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01161693
Eligibility Criteria:
Inclusion Criteria:
* Pregnancy greater than 37 weeks gestation
* ASA (American Society of Anaesthesiologists) I and II classification of health. Class I a normal healthy patient and II a patient with mild systemic disease (i.e. mild asthma)
* Mothers presenting to the assessment unit with ruptured membranes or in the early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery.
* Potential subjects need to be able to read and understand English, unless an independent translator is available.
Exclusion Criteria:
* Women having general anesthesia
* Mothers in active labour - 3cm or more dilated with regular coordinated contractions (3 in 10 minutes)
* ASA classification 3 or above
* Emergency cesarean delivery for fetal heart rate abnormalities
* Maternal age \<19
* BMI \>40. Obesity makes it more difficult to site the combined spinal epidural which could lead to delay in positioning the patient quickly following subarachnoid block. Obesity can result in increased venal caval compression in the supine wedge position causing epidural venous plexus engorgement and dural sac compression which may result in a high block. A later study will look at the effects of positioning in the obese patient
* Mothers with a history of known tolerance to opioids
* Uterine over distension- polyhydramnios, twin pregnancy and estimated fetal weight of over 4kg by ultrasound scan -Uterine over distension can result in increased aortocaval compression which may lead to engorgement of the epidural venous plexus and dural sac compression which may result in a high block.
* Height over 180cm and below 150cm
* Women presenting for urgent caesarean delivery will be excluded if there is less than 60 minutes between the time that the researcher can approach them regarding the study and the time that they will have their surgery.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT01161693
Study Brief:
Protocol Section:
NCT01161693