Acidosis, Cesarean Delivery Affecting Newborn, Maternal Hypotension, Spinal Aneshtesia
Conditions
Keywords
Fetal Acidosis, Maternal Hypotension, Ephedrine, Norepinephrine
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.
Interventions
DRUGNorepinephrine
Intravenous bolus of norepinephrine (5-10 µg) to treat spinal anesthesia-induced hypotension during cesarean section.
DRUGEphedrine
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.
Sponsors
mehmet özkılıç
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
No other parties are masked in this study.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of fetal acidosis (umbilical artery pH < 7.20) | Within 5 minutes after birth | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of maternal hypotension | Within 30 minutes post-spinal anesthesia | Defined as a decrease in systolic blood pressure \>20% from baseline or \<90 mmHg. Non-invasive blood pressure is monitored continuously. |
| Incidence of maternal tachycardia | During surgery | Maternal tachycardia is defined as a heart rate greater than 100 bpm recorded after vasopressor administration. Heart rate is continuously monitored using ECG. The outcome is the proportion of participants with tachycardia. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Apgar score at 1 minute | At 1 minute after delivery | Apgar Score (Appearance, Pulse, Grimace, Activity, Respiration) will be assessed by the attending neonatologist. The score ranges from 0 to 10, where higher scores indicate better neonatal condition. The outcome is the distribution of Apgar scores at 1 minute after birth. |
| Incidence of fetal tachycardia | At delivery | Fetal tachycardia is defined as a fetal heart rate greater than 160 bpm, assessed using cardiotocography prior to delivery. The outcome is the proportion of fetuses with tachycardia |
| Apgar score at 5 minutes | At 5 minutes after delivery | Apgar Score (Appearance, Pulse, Grimace, Activity, Respiration) will be assessed by the attending neonatologist. The score ranges from 0 to 10, where higher scores indicate better neonatal condition. The outcome is the distribution of Apgar scores at 5 minutes after birth. |
| Requirement for additional vasopressor doses | During surgery | The number and total dosage of additional vasopressor boluses (ephedrine in mg or norepinephrine in µg) required after the initial dose will be recorded for each participant. |
Countries
Turkey (Türkiye)
Outcome results
None listed