Clinical trial NCT05776186: Fetal Heart Rate Pattern After Spinal Anesthesia for Scheduled Uncomplicated Cesarean Section
Official title: Fetal Heart Rate Pattern Before, During, and After Spinal Anesthesia for Scheduled Uncomplicated Cesarean Section
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia
Keywords: cesarean section; spinal anesthesia ; fetal heart beat
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women for gestational age above 36 weeks

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fetal heart rate variability
timeFrame: 5 minutes after spinal anesthesia
Secondary outcomes:
measure: Neonatal outcome
timeFrame: 1 minute and 5 minutes after delivery
measure: Neonatal intensive care rate
timeFrame: baseline (admission)
measure: Umbilical vein analysis
timeFrame: within 5 minutes after delivery
measure: Maternal pain score
timeFrame: 0, 8, 24 hours after surgery
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References: