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:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT01810406
Eligibility Criteria:
Inclusion Criteria:
* Nulliparous parturients requesting regional analgesia for labour pain with singleton, vertex presentation fetuses at 37-42 week gestation in active labor with cervical dilation \< 5 cm.
* American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, e.g. controlled essential hypertension)
* Age ≥ 18 years (Standard within the obstetrical anesthesia literature)
* English-speaking
Exclusion Criteria:
* Contraindications to neuraxial analgesia (i.e. coagulopathy, systemic infection, neuropathy)
* Conditions associated with abnormal spinal anatomy which can affect local anesthetic spread (i.e. scoliosis, spina bifida, spinal instrumentation)
* Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity (Body Mass Index ≥ 35 kg/m2)
* Clinically significant diseases of pregnancy such as pregnancy-induced hypertension or preeclampsia (defined as systolic blood pressure (SBP) \> 160mmHg, diastolic blood pressure (DBP) \> 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria)
* Severe maternal cardiac disease
* Known fetal anomalies /intrauterine fetal demise
* Patient enrollment in another study involving a study medication within 30 days
* Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01810406
Study Brief:
Protocol Section:
NCT01810406