Effect of Neonatal Delivery Time on Umbilical Cord pH and Base Excess in Patients Undergoing Cesarean Section Under General and Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Umbilical Artery pH and Base Excess
研究概览
简要总结
The goal of this observational study is to evaluate the effect of neonatal delivery time on umbilical cord blood gas parameters in pregnant women undergoing elective cesarean section under general or spinal anesthesia. The study population consists of adult pregnant women aged 18-40 years with singleton term pregnancies scheduled for elective cesarean delivery.
The main questions it aims to answer are:
Is neonatal delivery time associated with changes in umbilical artery pH values under general and spinal anesthesia? Is neonatal delivery time associated with changes in umbilical artery base excess under general and spinal anesthesia? Researchers will compare cesarean sections performed under general anesthesia with those performed under spinal anesthesia to determine whether the relationship between delivery time and umbilical cord blood gas parameters differs between anesthesia techniques.
Participants will:
Undergo elective cesarean delivery under general or spinal anesthesia as part of routine clinical care Have neonatal delivery time recorded intraoperatively Have umbilical artery blood gas parameters (pH and base excess) measured immediately after birth as part of standard neonatal assessment
详细描述
This prospective, observational study will be conducted at a single tertiary care center and aims to investigate the relationship between neonatal delivery time and umbilical artery blood gas parameters in elective cesarean sections performed under general or spinal anesthesia. No experimental intervention will be applied, and all procedures will be carried out as part of routine clinical care.
Eligible participants will include adult pregnant women with singleton term pregnancies who are scheduled for elective cesarean delivery. The choice of anesthesia technique (general or spinal anesthesia) will be determined by standard clinical indications and patient preference, independent of study participation. No modification to anesthesia management or surgical technique will be made for the purposes of the study.
Neonatal delivery time will be defined as the interval between uterine incision and complete delivery of the neonate and will be recorded intraoperatively by the surgical team. Immediately after birth, umbilical artery blood samples will be obtained as part of routine neonatal assessment, and blood gas analysis will be performed to determine pH and base excess values.
Data will be collected using standardized case report forms and hospital electronic medical records. All data will be anonymized and coded prior to analysis to ensure participant confidentiality. The primary analyses will assess the association between neonatal delivery time and umbilical artery pH and base excess within each anesthesia group. Secondary analyses will compare blood gas parameters between general and spinal anesthesia groups after controlling for delivery time.
This study is expected to provide clinically relevant information regarding the impact of delivery time on neonatal metabolic status during cesarean delivery and to contribute to optimizing coordination between obstetric and anesthesia teams.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged 18-40 years Singleton pregnancy at ≥36+6 weeks of gestation Scheduled for elective cesarean section Planned delivery under general or spinal anesthesia Ability to provide written informed consent
排除标准
- •Emergency cesarean section Known fetal anomalies Multiple pregnancy Maternal comorbidities that may affect neonatal outcomes (e.g., diabetes mellitus, hypertension, preeclampsia) Conversion from spinal anesthesia to general anesthesia Failure to obtain umbilical artery blood gas sample or incomplete clinical data
研究组 & 干预措施
General Anesthesia
This cohort includes pregnant women undergoing elective cesarean section under general anesthesia as part of routine clinical care. The anesthesia technique is selected based on standard clinical indications and patient preference, independent of study participation. No experimental intervention is applied. Neonatal delivery time and umbilical artery blood gas parameters (pH and base excess) are recorded prospectively for observational analysis.
Spinal Anesthesia
This cohort includes pregnant women undergoing elective cesarean section under spinal anesthesia as part of routine clinical care. The anesthesia technique is determined according to standard clinical practice and patient preference, independent of study participation. No experimental intervention is performed. Neonatal delivery time and umbilical artery blood gas parameters (pH and base excess) are prospectively recorded for observational analysis.
结局指标
主要结局
Umbilical Artery pH and Base Excess
时间窗: Immediately after delivery
Umbilical artery pH and base excess will be measured from arterial cord blood samples obtained immediately after delivery as part of routine neonatal assessment. These parameters will be used to evaluate neonatal metabolic status and their association with neonatal delivery time in cesarean sections performed under general and spinal anesthesia.
次要结局
未报告次要终点
研究者
murat sahin
Medical Doctor
Sisli Hamidiye Etfal Training and Research Hospital