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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04716660
Eligibility Criteria:
Inclusion Criteria:
* women admitted to the Labor and Delivery unit at Mount Sinai Hospital that request and have no contraindications to receive epidural analgesia
* 18 years old or more
* capable of understanding and signing the written informed consent
* have no language barrier to respond to the level of sensory block assessment
* and have no conditions that could compromise the body sensitivity to cold.
Exclusion Criteria:
* unintentional dural puncture during labour epidural placement
* do not achieve adequate pain control 20 minutes after the loading dose (numeric rating scale (NRS)\>1 on a 0-10 NRS),
* deliver before 160 minutes following the loading dose
* require rescue boluses in the first 80 minutes after initiation of PIEB (that is, before the 2nd PIEB bolus)
* withdraw their consent.
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04716660
Study Brief:
Protocol Section:
NCT04716660