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

NCT ID: NCT06921473

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-12-15

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.

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 spinal anesthesia. Maternal hypotension is a frequent complication associated with spinal anesthesia, and the management of this condition is critical for maintaining adequate uteroplacental perfusion. While both ephedrine and norepinephrine are commonly used vasopressors, there is ongoing debate regarding their relative safety and efficacy, particularly in terms of fetal outcomes.

The primary aim of this study is to evaluate the incidence of fetal acidosis, defined as an umbilical artery pH < 7.20, in patients receiving either ephedrine or norepinephrine. Secondary outcomes include maternal blood pressure control, heart rate, incidence of maternal and fetal tachycardia, Apgar scores at 1 and 5 minutes, and the need for additional vasopressor support. A total of 100 pregnant women undergoing elective cesarean section will be enrolled, with 50 participants in each treatment group. All participants will receive standardized spinal anesthesia, and vasopressors will be titrated according to protocol.

The study is designed to inform clinical decision-making regarding optimal vasopressor selection in obstetric anesthesia, with a focus on balancing maternal hemodynamic stability and fetal well-being.

Conditions

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

Keywords

Fetal Acidosis; Maternal Hypotension; Ephedrine; Norepinephrine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Ephedrine Group

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

Group Type: ACTIVE_COMPARATOR

Ephedrine

Intervention Type: 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.

Norepinephrine Group

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

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

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

Interventions

Norepinephrine

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

Intervention Type: DRUG

Ephedrine

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.

Intervention Type: DRUG

Other Intervention Names

Steradin®; Ephedrine hydrochloride

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

mehmet özkılıç

OTHER

Sponsor Role: lead

Responsible Party

mehmet özkılıç

Specialist Doctor in Anesthesiology and Reanimation

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi Yaşargil Training and Research Hospital

Locations

SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi

Diyarbakır, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GYEAH-OB-NE-EF-001

Identifier Type: -

Identifier Source: org_study_id