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Clinical Trials/NCT05776186
NCT05776186
Recruiting
N/A

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

Taichung Veterans General Hospital1 site in 1 country50 target enrollmentNovember 29, 2022

Overview

Phase
N/A
Intervention
Spinal anesthesia with heavy bupivacaine
Conditions
Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia
Sponsor
Taichung Veterans General Hospital
Enrollment
50
Locations
1
Primary Endpoint
Fetal heart rate variability
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 29, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Before spinal anesthesia

Before spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.

Intervention: Spinal anesthesia with heavy bupivacaine

After spinal anesthesia

After spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.

Intervention: Spinal anesthesia with heavy bupivacaine

Outcomes

Primary Outcomes

Fetal heart rate variability

Time Frame: 5 minutes after spinal anesthesia

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

Secondary Outcomes

  • 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)

Study Sites (1)

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