SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi
Diyarbakır, 21070, Turkey (Türkiye)
NCT Number: NCT06921473
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.
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Notify Me18 year–45 year
Female
Interventional
Phase 4
Diyarbakır, 21070, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous bolus of norepinephrine (5-10 µg) to treat spinal anesthesia-induced hypotension during cesarean section.
Other names: Steradin®
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.
Other names: Ephedrine hydrochloride
Time frame: Within 5 minutes after birth
Fetal acidosis is defined as an umbilical artery blood pH < 7.20. Arterial blood will be collected from a double-clamped segment of the umbilical cord immediately after delivery and analyzed using a validated blood gas analyzer.
Time frame: Within 30 minutes post-spinal anesthesia
Defined as a decrease in systolic blood pressure >20% from baseline or <90 mmHg. Non-invasive blood pressure is monitored continuously.
Time frame: During surgery
Maternal tachycardia is defined as a heart rate greater than 100 bpm recorded after vasopressor administration. Heart rate is continuously monitored using ECG. The outcome is the proportion of participants with tachycardia.
Time frame: At 1 minute after delivery
Apgar Score (Appearance, Pulse, Grimace, Activity, Respiration) will be assessed by the attending neonatologist. The score ranges from 0 to 10, where higher scores indicate better neonatal condition. The outcome is the distribution of Apgar scores at 1 minute after birth.
Time frame: At 5 minutes after delivery
Apgar Score (Appearance, Pulse, Grimace, Activity, Respiration) will be assessed by the attending neonatologist. The score ranges from 0 to 10, where higher scores indicate better neonatal condition. The outcome is the distribution of Apgar scores at 5 minutes after birth.
Time frame: During surgery
The number and total dosage of additional vasopressor boluses (ephedrine in mg or norepinephrine in µg) required after the initial dose will be recorded for each participant.
Time frame: At delivery
Fetal tachycardia is defined as a fetal heart rate greater than 160 bpm, assessed using cardiotocography prior to delivery. The outcome is the proportion of fetuses with tachycardia
mehmet özkılıç
Other
Effect of Ephedrine and Norepinephrine on Fetal Acidosis During Cesarean Section Under Spinal Anesthesia: A Prospective, Randomized Controlled Trial
Acronym: NEO-FET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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