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Completed
NCT07842783
Norepinephrine Infusion vs Bolus vs Ephedrine for Blood Pressure Stability During Cesarean Delivery in Women With Preeclampsia
Conditions: Preeclampsia, Cesarean Birth, Hypotension During Surgery
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: Benha University
Location: Benha University Hospital Banhā
Summary
This randomized controlled trial will compare norepinephrine infusion, norepinephrine bolus, and ephedrine bolus for maintaining hemodynamic stability during spinal anesthesia for scheduled cesarean delivery in women with preeclampsia. Eighty-four eligible women will be randomly allocated in a 1:1:1 ratio to one of three treatment groups. The primary outcome is hemodynamic control during the first 20 minutes after spinal anesthesia, including the occurrence of hypotension, need for rescue vasopressors, and maintenance of blood pressure within ±20% of baseline. Secondary outcomes include severe hypotension, time to first hypotensive episode, vasopressor requirements, maternal adverse effects, fluid balance, and neonatal outcomes including Apgar scores, umbilical cord blood gases, and NICU admission.
Eligibility Criteria
Inclusion Criteria:
Women older than 18 years of age with preeclampsia. American Society of Anesthesiologists (ASA) physical status II-III. Preeclampsia defined by systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg on two measurements at least 4 hours apart in a previously normotensive woman, accompanied by proteinuria (≥300 mg/24 hours or equivalent) or evidence of end-organ dysfunction, such as thrombocytopenia, renal or hepatic impairment, pulmonary edema, or neurological symptoms.
Singleton pregnancy. Gestational age ≥37 weeks. Scheduled cesarean delivery under spinal anesthesia.
Exclusion Criteria:
Refusal to participate in the study. Chronic hypertension or chronic hypertension with preeclampsia. Comorbid conditions, including diabetes mellitus or cardiovascular disease. Suspected fetal compromise. Emergency cesarean section.
Source: ClinicalTrials.gov (NCT07842783). StuddyBuddy aggregates publicly available trial information.