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Fetal Heart Rate Pattern After Spinal Anesthesia for Scheduled Uncomplicated Cesarean Section

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05776186
Enrollment
50
Registered
2023-03-20
Start date
2022-11-29
Completion date
2023-12-31
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia

Keywords

cesarean section; spinal anesthesia ; fetal heart beat

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.

Interventions

DRUGSpinal anesthesia with heavy bupivacaine

Spinal anesthesia

Sponsors

Taichung Veterans General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age above 20 years 2. Singleton 3. Gestational age above 36 weeks 4. Scheduled Cesarean section at VGHTC 5. Eligible for spinal anesthesia 6. Inform consent

Exclusion criteria

1. ASA \> 3 2. Prenatal examination reveal suspect neonatal congenital heart disease, heart failure, arrythymia or hydrops fetalis which could affect fetal heart beat 3. Regular uterine contraction, premature rupture of membrane or vaginal bleeding before scheduled C/S on prenatal clinic 4. Anticipate vaginal delivery initially but shift to C/S for prolong labor, FHB deceleration or other reason 5. Patients cannot make decision for language barrier, education condition or phsycological disease 6. Register in other study already

Design outcomes

Primary

MeasureTime frameDescription
Fetal heart rate variability5 minutes after spinal anesthesiaFetal heart rate deceleration (normal \> 100 beats per minute)

Secondary

MeasureTime frameDescription
Neonatal outcome1 minute and 5 minutes after deliveryAPGAR score\_1 minute, APGAR score\_5 minute ( APGAR score: 0-10 points)
Neonatal intensive care ratebaseline (admission)NICU admission rate
Umbilical vein analysiswithin 5 minutes after deliveryUmbilical vein blood gas analysis, including pH, O2, CO2, HgB, electrolyte
Maternal pain score0, 8, 24 hours after surgeryVisual analog scale ( VAS score 0-10)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026