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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05543694
Eligibility Criteria:
Inclusion Criteria:
* Parturient with no major co-morbidities
* Singleton, vertex gestation at term (37-42 weeks)
* Less than or equal to 5 cm dilation
* Desire to receive epidural labor analgesia
* Numerical Rating Scale greater or equal to 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.
Exclusion Criteria:
* Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
* Any contraindication to the administration of an epidural technique
* History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
* Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. history of uterine rupture). NB: Exception-trial of labor after cesarean delivery (TOLAC) will be eligible.
* Evidence of anticipated fetal anomalies
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05543694
Study Brief:
Protocol Section:
NCT05543694