Preloading to Prevent Hypotension During Cesarean Section
Pre-optimization of Fluid Status to Prevent Hypotension by Non-invasive Arterial Pressure Monitor During Cesarean Section
1 other identifier
interventional
71
1 country
1
Brief Summary
Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in caesarean section can effectively reduce the incidence of hypotension and fetal complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedStudy Start
First participant enrolled
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2019
CompletedJanuary 9, 2020
July 1, 2019
1.8 years
December 22, 2016
January 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of maternal hypotension
delivery
Secondary Outcomes (2)
Dosage of vasopressor
delivery
Total fluid volume
delivery
Study Arms (2)
Goal-directed preloading
EXPERIMENTALFluid therapy: Within 30 minutes before spinal anaesthesia, repeat "Ringer's Injection" 3ml/kg within 3 minutes with 1-min gap until change in SV (ΔSV) \<5%
Preloading
ACTIVE COMPARATORFluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml "Ringer's injection" with a pressurizer within 15 minutes.
Interventions
Goal directed Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat "Ringer's Injection" 3ml/kg within 3 minutes with 1-min gap until ΔSV\<5%
Inject marcaine and fentanyl to CSF for anaesthesia
Eligibility Criteria
You may qualify if:
- y/o parturient
- Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo cesarean section
You may not qualify if:
- Emergent C/S
- BMI\>35kg/m2
- Height \<150cm or \>175 cm
- Patients with major cardiovascular disease, preeclampsia or eclampsia.
- Gestational age \< 36wks
- Multiple pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NTUH
Taipei, Taiwan
Related Publications (1)
Yang SH, Lin YS, Lee CN, Cheng YJ, Chen YH, Chiu HC, Wu CY. Implications of Continuous Noninvasive Finger Cuff Arterial Pressure Device Use during Cesarean Delivery for Goal-Directed Fluid Therapy Preload Optimization: A Randomized Controlled Trial. Biomed Res Int. 2021 Mar 28;2021:6685584. doi: 10.1155/2021/6685584. eCollection 2021.
PMID: 33855080DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YiShiuan Lin
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2016
First Posted
January 6, 2017
Study Start
February 3, 2017
Primary Completion
November 29, 2018
Study Completion
June 9, 2019
Last Updated
January 9, 2020
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share