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

Study 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.

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

Conditions
-----------------
Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia

Intervention / Treatment
-----------------
* Drug: Spinal anesthesia with heavy bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 20 years Singleton Gestational age above 36 weeks Scheduled Cesarean section at VGHTC Eligible for spinal anesthesia Inform consent Exclusion Criteria: ASA > 3 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before spinal anesthesia<br>Before spinal anesthesia with heavy bupivacaine 12.5 mg is administrated. | Drug: Spinal anesthesia with heavy bupivacaine<br>* Spinal anesthesia<br>|
| After spinal anesthesia<br>After spinal anesthesia with heavy bupivacaine 12.5 mg is administrated. | Drug: Spinal anesthesia with heavy bupivacaine<br>* Spinal anesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal heart rate variability | Fetal heart rate deceleration (normal > 100 beats per minute) | 5 minutes after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal outcome | APGAR score_1 minute, APGAR score_5 minute ( APGAR score: 0-10 points) | 1 minute and 5 minutes after delivery | 
| Neonatal intensive care rate | NICU admission rate | baseline (admission) | 
| Umbilical vein analysis | Umbilical vein blood gas analysis, including pH, O2, CO2, HgB, electrolyte | within 5 minutes after delivery | 
| Maternal pain score | Visual analog scale ( VAS score 0-10) | 0, 8, 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean section; spinal anesthesia ; fetal heart beat