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

Recruiting

• Conditions: Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia
• Interventions: Drug: Spinal anesthesia with heavy bupivacaine

• Registration Number: NCT05776186
• Lead Sponsor: Taichung Veterans General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-29
• Study First Submitted: 2022-12-02
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-20
• Last Update Posted: 2023-03-20
• Primary Completion: 2023-10-13
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Before spinal anesthesia	Spinal anesthesia with heavy bupivacaine	Before spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.
After spinal anesthesia	Spinal anesthesia with heavy bupivacaine	After spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.

Primary Outcome Measures

Name	Time	Method
Fetal heart rate variability	5 minutes after spinal anesthesia	Fetal heart rate deceleration (normal \> 100 beats per minute)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan