跳至主要内容
临床试验/NCT05776186
NCT05776186招募中不适用

Fetal Heart Rate Pattern Before, During, and After Spinal Anesthesia for Scheduled Uncomplicated Cesarean Section

Taichung Veterans General Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Fetal heart rate variability

研究概览

简要总结

Spinal anesthesia may cause sympathetic blockade which decrease peripheral vascular resistance and bradycardia and then hypotension. Maternal hypotension could cause immediate fetus heart beat (FHB) deceleration and postpartum acidosis. Both intravenous hydration or vasopressor during hypotension could prevent maternal hypotension efficiently. Although there were many articles discussion about maternal hypotension and fetal heart rate variation during epidural labor analgesia, the studies about FHB variation during spinal anesthesia is not much. In one literature in 1960, if maternal blood pressure below 60-80 mmHg, FHB deceleration could happen in 5 minutes. In modern medical management, FHB change during and after spinal anesthesia is an interesting topic. The most relevant study was published by NTUH in 2015, which transformed EKG signal to possible FHB change.

The parturient will have FHB recording for 20 minutes in the day before operation. On the operation day, after proper position by the anesthetic staff (lateral position or sitting position), spinal anesthesia will performed by obstetric anesthesiologist and the lying down for supine position. Before the baby was delivered by cesarean section no FHB will be monitored. The aim of the study is continuous FHB monitor and analysis after spinal anesthesia for 5-10 minutes to improve fetal physiology knowledge and providing basic information for future study.

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
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age above 20 years
  • Gestational age above 36 weeks
  • Scheduled Cesarean section at VGHTC
  • Eligible for spinal anesthesia
  • Inform consent

排除标准

  • Prenatal examination reveal suspect neonatal congenital heart disease, heart failure, arrythymia or hydrops fetalis which could affect fetal heart beat
  • Regular uterine contraction, premature rupture of membrane or vaginal bleeding before scheduled C/S on prenatal clinic
  • Anticipate vaginal delivery initially but shift to C/S for prolong labor, FHB deceleration or other reason
  • Patients cannot make decision for language barrier, education condition or phsycological disease
  • Register in other study already

研究组 & 干预措施

Before spinal anesthesia

Before spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.

干预措施: Spinal anesthesia with heavy bupivacaine (Drug)

After spinal anesthesia

After spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.

干预措施: Spinal anesthesia with heavy bupivacaine (Drug)

结局指标

主要结局

Fetal heart rate variability

时间窗: 5 minutes after spinal anesthesia

Fetal heart rate deceleration (normal \> 100 beats per minute)

次要结局

  • Umbilical vein analysis(within 5 minutes after delivery)
  • Maternal pain score(0, 8, 24 hours after surgery)
  • Neonatal intensive care rate(baseline (admission))
  • Neonatal outcome(1 minute and 5 minutes after delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验