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Completed

NCT Number: NCT06921473

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

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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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi

Diyarbakır, 21070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women aged between 18 and 45 years
  • Singleton pregnancy at ≥ 37 weeks of gestation
  • Scheduled for elective cesarean section under spinal anesthesia
  • ASA (American Society of Anesthesiologists) physical status classification I or II
  • Ability to understand and sign the informed consent form

Exclusion criteria

  • History of allergy or hypersensitivity to ephedrine or norepinephrine
  • Multiple gestation pregnancies
  • Diagnosis of pre-eclampsia, eclampsia, or other hypertensive disorders of pregnancy
  • Known cardiovascular disease or arrhythmia
  • Placental abnormalities (e.g., placenta previa, placental abruption)
  • Fetal structural or chromosomal anomalies
  • Morbid obesity (BMI > 40 kg/m²)
  • Refusal to participate or inability to provide informed consent

Treatment and study plan

norepinephrine

Drug

Intravenous bolus of norepinephrine (5-10 µg) to treat spinal anesthesia-induced hypotension during cesarean section.

Other names: Steradin®

Ephedrine

Drug

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

Primary outcomes

  1. Incidence of fetal acidosis (umbilical artery pH < 7.20)

    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.

Secondary outcomes

  1. Incidence of maternal hypotension

    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.

  2. Incidence of maternal tachycardia

    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.

Other outcomes

  1. Apgar score at 1 minute

    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.

  2. Apgar score at 5 minutes

    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.

  3. Requirement for additional vasopressor doses

    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.

  4. Incidence of fetal tachycardia

    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

Sponsors and collaborators

Lead sponsor

mehmet özkılıç

Other

Registry information

Official study title

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

Acronym: NEO-FET

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Dec 29, 2025

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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