Fetal Heart Rate Pattern After Spinal Anesthesia for Sche... | NCT05776186

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

NCT05776186

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Mar 20, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia

Interventions

Spinal anesthesia with heavy bupivacaine

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 29, 2022Actual

Primary Completion Date

Oct 13, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Dec 2, 2022

First Submission Date that Met QC Criteria

Mar 16, 2023

First Posted Date

Mar 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2023

Last Update Posted Date

Mar 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Before spinal anesthesia		Before spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.	Drug: Spinal anesthesia with heavy bupivacaine
After spinal anesthesia		After spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.	Drug: Spinal anesthesia with heavy bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinal anesthesia with heavy bupivacaine	Drug	Spinal anesthesia	After spinal anesthesia Before spinal anesthesia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnancy women

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Pregnant women for gestational age above 36 weeks

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Veterans General Hospital	Recruiting	Taichung			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000775	Anesthesia, Spinal

Ancestor Terms

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia

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Browse Branches

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