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 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT03044392
Eligibility Criteria:
Inclusion Criteria:
* • American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease)
* Spontaneous labour
* Nulliparous parturient
* Single gestations ≥ 36 weeks
* English speaking
* Age 18-45 years
* Vertex presentation
* Requesting an epidural for labour analgesia
* Cervical dilation less than 2 cm or greater than 6 cm at the time of initiation of neuraxial analgesia
Exclusion Criteria:
* • Use of IV opioids within 1 hour of initiating the epidural
* Use of nitrous oxide after initiating the epidural pump
* Contraindications to neuraxial analgesia (i.e. coagulopathy, infection, neuropathy)
* Abnormal spinal anatomy (i.e. scoliosis, spina bifida, spinal instrumentation)
* Height \< 5'0" or BMI ≥ 40 kg/m2
* Chronic analgesics
* Diseases of pregnancy (i.e. hypertension, preeclampsia, gestational diabetes)
* Severe maternal cardiac disease
* Known fetal anomalies /intrauterine fetal demise
* Physical or psychiatric condition which may impair cooperation
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03044392
Study Brief:
Protocol Section:
NCT03044392