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

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.

Study Overview

• Status: Recruiting
• Conditions: Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia
• Intervention / Treatment: Drug: Spinal anesthesia with heavy bupivacaine

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Szu-Ling Chang, M.D.; Phone Number: 4101 886-4-23592525; Email: irbtc@vghtc.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women for gestational age above 36 weeks

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before spinal anesthesia; Before spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.	Drug: Spinal anesthesia with heavy bupivacaine; Spinal anesthesia
After spinal anesthesia; After spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.	Drug: Spinal anesthesia with heavy bupivacaine; Spinal anesthesia

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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Anticipated): October 13, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cesarean section; spinal anesthesia ; fetal heart beat
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: CF22379A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No