Status:

COMPLETED

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

Lead Sponsor:

mehmet özkılıç

Conditions:

Cesarean Delivery Affecting Newborn

Acidosis

Eligibility:

FEMALE

18-45 years

Phase:

PHASE4

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 anesthesi...

Detailed Description

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 spi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 15 2025

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT06921473

Start Date

September 1 2025

End Date

December 15 2025

Last Update

December 29 2025

Active Locations (1)

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SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi

Diyarbakır, Turkey (Türkiye), 21070