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

NCT06921473 | Completed Phase 4

• 1 other identifier: GYEAH-OB-NE-EF-001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Fetal Acidosis; Maternal Hypotension; Ephedrine; Norepinephrine

Outcome Measures

Primary Outcomes (1)

• Incidence of fetal acidosis (umbilical artery pH < 7.20)

  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.

  Within 5 minutes after birth

Secondary Outcomes (2)

• Incidence of maternal hypotension

  Within 30 minutes post-spinal anesthesia

• Incidence of maternal tachycardia

  During surgery

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 in this group will receive intravenous bolus doses of ephedrine (5-10 mg) to manage spinal anesthesia-induced hypotension during cesarean section.

Drug: Ephedrine

Norepinephrine Group

EXPERIMENTAL

Participants in this group will receive intravenous bolus doses of norepinephrine (5-10 µg) to manage spinal anesthesia-induced hypotension during cesarean section.

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

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

Also known as: Steradin®

Norepinephrine Group

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.

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 qualify if:

• 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

You may not qualify if:

• 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

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: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: No other parties are masked in this 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 receive either ephedrine or norepinephrine intravenously for the prevention of spinal anesthesia-induced hypotension during cesarean section. Randomization is stratified, and the study drugs are prepared and administered in a blinded manner.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 10, 2025
• Study Start: September 1, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 15, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)