Ephedrine Versus Norepinephrine and Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia

NCT06921473 | Completed Phase 4

• 1 other identifier: GYEAH-OB-NE-EF-001
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Ephedrine; Norepinephrine; Postspinal Hypotension; Umbilical Arterial pH; Fetal Acid-Base Status; Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• Umbilical arterial pH

  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

Secondary Outcomes (3)

• Maternal hypotension

  From spinal anesthesia until delivery

• Incidence of neonatal acidosis (UA pH <7.20)

  Immediately after delivery

• Maternal heart rate response

  From spinal anesthesia until delivery / during surger

Other Outcomes (4)

• Apgar score at 1 minute

  At 1 minute after delivery

• Apgar score at 5 minutes

  At 5 minutes after delivery

• Requirement for additional vasopressor doses

  During surgery

Study Arms (2)

Ephedrine Group

ACTIVE COMPARATOR

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.

Drug: Ephedrine

Norepinephrine Group

EXPERIMENTAL

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.

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

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.

Also known as: Steradin®

Norepinephrine Group

Ephedrine DRUG

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.

Also known as: Ephedrine hydrochloride

Ephedrine Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• mehmet özkılıç: lead

Study Sites (1)

SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi

Diyarbakır, 21070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acidosis

Interventions

Norepinephrine; Ephedrine

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Propanolamines; Propanols; Phenethylamines; Ethylamines

Study Officials

• Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD

  Gazi Yaşargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Study medications were prepared by an independent investigator not involved in clinical care or outcome assessment. Ephedrine and norepinephrine were prepared in visually identical, colorless syringes labeled only with the randomization code. Participants, treating anesthesiologists, and outcome assessors remained blinded to treatment allocation throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Doctor in Anesthesiology and Reanimation

Model Details: This is a prospective, randomized, double-blind, two-arm parallel assignment study. Participants are allocated in a 1:1 ratio to either the ephedrine or norepinephrine group before spinal anesthesia. The allocated vasopressor is administered intravenously only if postspinal hypotension develops. Randomization is performed using a computer-generated block randomization sequence with varying block sizes. Study medications are prepared in visually identical syringes by an independent investigator, and participants, treating anesthesiologists, and outcome assessors remain blinded to group allocation.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 10, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)