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

4. oktober 2026 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

155

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Legemiddel: 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.

Andre navn:
  • Efedrinhydroklorid
Eksperimentell: 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.
Legemiddel: 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.

Andre navn:
  • Steradin®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Umbilical arterial pH
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maternal hypotension
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Apgar score at 1 minute
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Immediately after delivery

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

mehmet özkılıç

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2025

Primær fullføring (Faktiske)

1. desember 2025

Studiet fullført (Faktiske)

1. desember 2025

Datoer for studieregistrering

Først innsendt

1. april 2025

Først innsendt som oppfylte QC-kriteriene

8. april 2025

Først lagt ut (Faktiske)

10. april 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GYEAH-OB-NE-EF-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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