NCT06921473

Effect of Ephedrine vs. Norepinephrine on Prevention of Fetal Acidosis During Cesarean Section Under Spinal Anesthesia

Effect of Ephedrine and Norepinephrine on Fetal Acidosis During Cesarean Section Under Spinal Anesthesia: A Prospective, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: mehmet özkılıç · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study compares the effects of two medications, ephedrine and norepinephrine, on the baby (fetus) when used to treat low blood pressure (hypotension) during cesarean section under spinal anesthesia. Hypotension is a common side effect during spinal anesthesia, and it can affect the blood flow to the baby. Both medications are commonly used to manage this condition. The goal of the study is to determine which medication is more effective and safer for the baby, by measuring the pH level in the umbilical artery after birth. The study will also examine maternal blood pressure, heart rate, and the baby's Apgar scores.

Detailed description

This is a prospective, randomized, double-blind, controlled clinical trial designed to compare the effects of ephedrine and norepinephrine on fetal acidosis during cesarean section performed under spinal anesthesia. Maternal hypotension is a frequent complication associated with spinal anesthesia, and the management of this condition is critical for maintaining adequate uteroplacental perfusion. While both ephedrine and norepinephrine are commonly used vasopressors, there is ongoing debate regarding their relative safety and efficacy, particularly in terms of fetal outcomes. The primary aim of this study is to evaluate the incidence of fetal acidosis, defined as an umbilical artery pH \< 7.20, in patients receiving either ephedrine or norepinephrine. Secondary outcomes include maternal blood pressure control, heart rate, incidence of maternal and fetal tachycardia, Apgar scores at 1 and 5 minutes, and the need for additional vasopressor support. A total of 100 pregnant women undergoing elective cesarean section will be enrolled, with 50 participants in each treatment group. All participants will receive standardized spinal anesthesia, and vasopressors will be titrated according to protocol. The study is designed to inform clinical decision-making regarding optimal vasopressor selection in obstetric anesthesia, with a focus on balancing maternal hemodynamic stability and fetal well-being.

Conditions

• Cesarean Delivery Affecting Newborn
• Acidosis
• Maternal Hypotension
• Spinal Aneshtesia

Interventions

Type	Name	Description
DRUG	Norepinephrine	Intravenous bolus of norepinephrine (5-10 µg) to treat spinal anesthesia-induced hypotension during cesarean section.
DRUG	Ephedrine	Intravenous bolus of 5-10 mg ephedrine administered as needed to treat maternal hypotension following spinal anesthesia during elective cesarean section. The drug is prepared in identical, unlabeled syringes to ensure blinding.

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-12-12
• Completion: 2025-12-15
• First posted: 2025-04-10
• Last updated: 2025-12-29

Locations

1 site across 1 country: Turkey (Türkiye)