Clinical trial NCT06921473: Effect of Ephedrine vs. Norepinephrine on Prevention of Fetal Acidosis During Cesarean Section Under Spinal Anesthesia
Official title: Effect of Ephedrine and Norepinephrine on Fetal Acidosis During Cesarean Section Under Spinal Anesthesia: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cesarean Delivery Affecting Newborn
Acidosis
Maternal Hypotension
Spinal Aneshtesia
Keywords: Fetal Acidosis
Maternal Hypotension
Ephedrine
Norepinephrine
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of fetal acidosis (umbilical artery pH < 7.20)
timeFrame: Within 5 minutes after birth
Secondary outcomes:
measure: Incidence of maternal hypotension
timeFrame: Within 30 minutes post-spinal anesthesia
measure: Incidence of maternal tachycardia
timeFrame: During surgery
Other outcomes:
measure: Apgar score at 1 minute
timeFrame: At 1 minute after delivery
measure: Apgar score at 5 minutes
timeFrame: At 5 minutes after delivery
measure: Requirement for additional vasopressor doses
timeFrame: During surgery
measure: Incidence of fetal tachycardia
timeFrame: At delivery
Locations:
Study officials:
affiliation: Gazi Yaşargil Training and Research Hospital
name: Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD
role: PRINCIPAL_INVESTIGATOR
References: