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 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT00781157
Eligibility Criteria:
Inclusion Criteria:
1. Non-emergent cesarean delivery with planned regional anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery)
2. American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
3. Age ≥ 18 years (Standard within the obstetrical literature)
4. Term gestational age
5. English-speaking
Exclusion Criteria:
1. Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study, typically have an exaggerated response to vasopressors, and the blood pressure cuff occasionally needs to be replaced by an intraarterial catheter due to limitations in size)
2. Height \< 5'0" (Women \< 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study)
3. Laboring women
4. Urgent or emergency cesarean delivery
5. Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP) \> 160mmHg, diastolic blood pressure (DBP) \> 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria
6. Severe maternal cardiac disease
7. Diabetes type I
8. Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants
9. Fetal anomalies
10. Failed spinal anesthesia
11. Subject enrollment in another study involving a study medication within 30 days of CD
12. 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:
NCT00781157
Study Brief:
Protocol Section:
NCT00781157