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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | Intravenous bolus of norepinephrine (5-10 µg) to treat spinal anesthesia-induced hypotension during cesarean section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of maternal hypotension | Defined as a decrease in systolic blood pressure >20% from baseline or <90 mmHg. Non-invasive blood pressure is monitored continuously. | Within 30 minutes post-spinal anesthesia |
| Incidence of maternal tachycardia |
| Measure | Description | Time Frame |
|---|---|---|
| Apgar score at 1 minute | 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. | At 1 minute after delivery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD | Gazi Yaşargil Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi | Diyarbakır | 21070 | Turkey (Türkiye) |
IPD will not be shared because data sharing was not included in the approved study protocol.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2012 |
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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.
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No other parties are masked in this study.
| 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. |
|
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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.
| During surgery |
| Apgar score at 5 minutes |
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. |
| At 5 minutes after delivery |
| Requirement for additional vasopressor doses | 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. | During surgery |
| Incidence of fetal tachycardia | 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 | At delivery |
| Jun 12, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D004809 | Ephedrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011412 | Propanolamines |
| D020005 | Propanols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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