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 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT04011150
Eligibility Criteria:
Inclusion Criteria:
* Healthy (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation);
* Singleton fetus;
* In early labor stage (cervical dilation ≤5cm);
* Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol.
Exclusion Criteria:
* Non-cephalic fetal presentation;
* Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
* Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours;
* Dural puncture/ suspected dural puncture at initiation of CSEA.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT04011150
Study Brief:
Protocol Section:
NCT04011150