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Ephedrine Versus Norepinephrine and Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia (NEO-FET)

4 oktober 2026 uppdaterad av: mehmet özkılıç

Comparative Effects of Ephedrine and Norepinephrine on Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia: A Randomized Double-Blind Study

This study compares ephedrine and norepinephrine for the treatment of low blood pressure (hypotension) that may occur during cesarean delivery under spinal anesthesia. Maternal hypotension can reduce uteroplacental blood flow and may affect fetal well-being. Both medications are commonly used to restore blood pressure. The primary aim of this study is to compare their effects on neonatal acid-base status, assessed by umbilical arterial pH measured immediately after birth. Secondary outcomes include other umbilical arterial blood gas parameters, maternal blood pressure and heart rate, vasopressor requirements, maternal adverse events, and neonatal Apgar scores.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a prospective, randomized, double-blind, controlled clinical trial designed to compare the effects of ephedrine and norepinephrine on fetal acid-base status during elective cesarean delivery under spinal anesthesia. Maternal hypotension is a common complication of spinal anesthesia and may reduce uteroplacental perfusion. Ephedrine and norepinephrine are both used to restore maternal blood pressure, but their comparative effects on fetal acid-base balance and maternal hemodynamics remain incompletely defined.

The primary aim of the study is to compare umbilical arterial pH between patients treated with ephedrine and those treated with norepinephrine for postspinal hypotension. Secondary outcomes include other umbilical arterial blood gas parameters, including pCO₂, bicarbonate, base excess, and lactate; the incidence of neonatal acidosis defined as umbilical arterial pH <7.20; Apgar scores at 1 and 5 minutes; maternal systolic blood pressure and heart rate; vasopressor requirements; and maternal adverse events.

A total of 155 parturients were randomized in a 1:1 ratio before spinal anesthesia. Because the study drugs were administered only when postspinal hypotension occurred, the analysis population consisted of randomized participants who developed hypotension and received the allocated vasopressor. This resulted in 102 participants in the final analysis population, including 50 in the ephedrine group and 52 in the norepinephrine group.

All randomized participants underwent a standardized spinal anesthesia protocol. Postspinal hypotension was treated with repeated intravenous boluses of either ephedrine 5 mg or norepinephrine 5 µg according to the allocated treatment arm. The study was designed to compare fetal acid-base effects and maternal hemodynamic responses associated with these two vasopressor strategies.

Studietyp

Interventionell

Inskrivning (Faktisk)

155

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Turkiet (Türkiye)
      • Diyarbakır, Turkiet (Türkiye), 21070
        • SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

nclusion Criteria:

  • Women aged 18-45 years
  • Singleton term pregnancy (≥37 weeks of gestation)
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

  • Hypertensive disorders of pregnancy
  • Known systemic disease
  • Multiple gestation
  • Emergency cesarean delivery
  • Contraindication to spinal anesthesia
  • Known allergy to the study medications
  • Pre-diagnosed fetal growth restriction identified using standardized growth curves and pathological Doppler findings
  • Suspected fetal distress
  • Oligohydramnios
  • Known congenital fetal anomalies

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Ephedrine Group

Participants allocated to this group received intravenous ephedrine 5 mg boluses for the treatment of postspinal hypotension. Additional 5 mg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved.
Läkemedel: Ephedrine

Intravenous ephedrine 5 mg bolus administered for the treatment of postspinal hypotension during elective cesarean delivery. Additional 5 mg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved.

Andra namn:
  • Efedrinhydroklorid
Experimentell: Norepinephrine Group

Participants allocated to this group received intravenous norepinephrine 5 µg boluses for the treatment of postspinal hypotension. Additional 5 µg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved.
Läkemedel: Norepinephrine

Intravenous norepinephrine 5 µg bolus administered for the treatment of postspinal hypotension during elective cesarean delivery. Additional 5 µg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved.

Andra namn:
  • Steradin®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Umbilical arterial pH
Tidsram: Immediately after delivery

Umbilical arterial pH measured immediately after delivery from an arterial blood sample obtained from a double-clamped segment of the umbilical cord and analyzed within 5 minutes using a blood gas analyzer.
Immediately after delivery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maternal hypotension
Tidsram: From spinal anesthesia until delivery

Postspinal hypotension was defined as a decrease in systolic blood pressure to less than 80% of the baseline value. The number and duration of hypotensive episodes were recorded.
From spinal anesthesia until delivery
Incidence of neonatal acidosis (UA pH <7.20)
Tidsram: Immediately after delivery

Incidence of neonatal acidosis, defined as an umbilical arterial pH <7.20, determined from an umbilical arterial blood sample obtained immediately after delivery and analyzed using a point-of-care blood gas analyzer.
Immediately after delivery
Maternal heart rate response
Tidsram: From spinal anesthesia until delivery / during surger

Maternal heart rate was recorded after spinal anesthesia and during periods requiring vasopressor administration. Temporal heart rate changes and the occurrence of tachycardia were recorded.
From spinal anesthesia until delivery / during surger

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Apgar score at 1 minute
Tidsram: 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.
At 1 minute after delivery
Apgar score at 5 minutes
Tidsram: 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.
At 5 minutes after delivery
Requirement for additional vasopressor doses
Tidsram: During surgery

The number of vasopressor boluses and the total amount of ephedrine (mg) or norepinephrine (µg) administered for treatment of postspinal hypotension were recorded.
During surgery
Neonatal heart rate after delivery
Tidsram: Immediately after delivery

Neonatal heart rate measured after delivery and compared between the ephedrine and norepinephrine groups.
Immediately after delivery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

mehmet özkılıç

Utredare

  • Huvudutredare: Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD, Gazi Yaşargil Training and Research Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2025

Primärt slutförande (Faktisk)

1 december 2025

Avslutad studie (Faktisk)

1 december 2025

Studieregistreringsdatum

Först inskickad

1 april 2025

Först inskickad som uppfyllde QC-kriterierna

8 april 2025

Första postat (Faktisk)

10 april 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GYEAH-OB-NE-EF-001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

IPD will not be shared because data sharing was not included in the approved study protocol.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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