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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06107335
Eligibility Criteria:
Inclusion Criteria:
* Gestational age greater or equal to 24 weeks
* Diagnosis of preeclampsia with severe features \[Pre-eclampsia is defined as high blood pressure after 20 weeks with or without proteinuria. Pre-eclampsia with severe features is defined as the presence of preeclampsia with any of the following features: severe hypertension (blood pressure ≥160/110 mmHg on two separate occasions); thrombocytopenia (platelet count \<100,000 per microliter); impaired liver function (elevated liver transaminases to twice the normal concentration or severe persistent right upper quadrant or epigastric pain not responsive to medications); progressive renal insufficiency with a serum creatinine level of \>1.1 mg/dl or doubling of the serum creatinine level in the absence of other renal disease; pulmonary edema or unexplained new-onset cerebral symptoms (headache) unresponsive to medications or visual disturbances.\]
* Scheduled Cesarean Delivery
* Unscheduled Cesarean Delivery with the goal to proceed to the operating room within no less than 30 minutes due to concern for maternal or fetal status that is not immediately life threatening.
* Requiring Neuraxial Anesthesia (spinal or CSE)
Exclusion Criteria:
* Patient declines to participate in the study
* Labor
* Contraindications to the use of neuraxial anesthesia (coagulopathy, infection at the insertion site, intracranial mass etc.)
* Unscheduled Cesarean Delivery with the goal to proceed to the operating room immediately for delivery of the baby due to imminent/unavoidable threat to the life of the mother or fetus.
* The use of or conversion to General Anesthesia
* Non-reassuring fetal status including the presence of cardiac or multi-system anomalies, category III tracing etc.
* Significant maternal cardiopulmonary disease including pulmonary hypertension, ischemic heart disease with systolic dysfunction, pulmonary edema etc.
* Significant intraoperative events (such as hemorrhage) requiring administration of multiple blood products and ICU admission.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06107335
Study Brief:
Protocol Section:
NCT06107335