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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT03439358
Eligibility Criteria:
Inclusion Criteria:
1. Gestational age of ≥37 weeks
2. Women who are ≥ 19 years old
3. Women undergoing Cesarean delivery under lidocaine top-up via a preexisting epidural catheter inserted for labor analgesia
4. American Society of Anesthesiologist (ASA) Physical Status class 1 or 2
Exclusion Criteria:
1. Emergency Cesarean delivery with limited time for informed consent
2. Women who have received MgSO4 prior to study enrollment
3. Indication for alternative mode of anesthesia for Cesarean delivery (e.g., general anesthesia)
4. Medical conditions or medications that could lead to tremor or shivering. (e.g., movement disorder, untreated thyroid disease) or mask tremor or shivering (e.g., beta-blocker, benzodiazepine, anticonvulsants)
5. Active shivering at time of recruitment
6. Inability to read and understand English for the purpose of informed consent
7. Contraindications to receiving MgSO4 (hypersensitivity reactions, respiratory rate \<16breaths/min, absent reflexes, urine output \<100 mL during the previous 4 hours, renal failure, or hypocalcemia)
8. History of previous postpartum hemorrhage
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT03439358
Study Brief:
Protocol Section:
NCT03439358