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Preloading to Prevent Hypotension During Cesarean Section

Primary Purpose

Obstetric Anesthesia Problems

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fluid therapy
Spinal anaesthesia
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Anesthesia Problems focused on measuring Anesthesia, Obstetric, fluid therapy, cesarean section, spinal anesthesia

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria:

  1. 20-45 y/o parturient
  2. Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo cesarean section

Exclusion criteria:

  1. Emergent C/S
  2. BMI>35kg/m2
  3. Height <150cm or >175 cm
  4. Patients with major cardiovascular disease, preeclampsia or eclampsia.
  5. Gestational age < 36wks
  6. Multiple pregnancy

Sites / Locations

  • NTUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Goal-directed preloading

Preloading

Arm Description

Fluid 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%

Fluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml "Ringer's injection" with a pressurizer within 15 minutes.

Outcomes

Primary Outcome Measures

Incidence of maternal hypotension

Secondary Outcome Measures

Dosage of vasopressor
Total fluid volume

Full Information

First Posted
December 22, 2016
Last Updated
January 6, 2020
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03013140
Brief Title
Preloading to Prevent Hypotension During Cesarean Section
Official Title
Pre-optimization of Fluid Status to Prevent Hypotension by Non-invasive Arterial Pressure Monitor During Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
June 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Spinal anesthesia in the cesarean section often causes significant peripheral vascular dilatation, decreases blood pressure and cardiac output reduction which leads to maternal nausea, vomiting, dizziness and uteroplacental hypoperfusion. Infusion therapy and the use of vasopressor can prevent and treat the incidence of hypotension. Appropriate fluid therapy can not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. In the present study, perioperative goal directed fluid therapy is used. The non-invasive continuous hemodynamic monitor is used in this study, and the parameters (blood pressure (BP), stroke volume(SV), stroke volume variation (SVV), cardiac output (CO)) are used to determine the parameters of the blood transfusion in cesarean section as infusion guidelines. The application of Clearsight system to the pre-infusion of target-guided crystalloid solution is compared with the infusion of quantitative crystalline solution in the hope of reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving uteroplacental perfusion and reducing the incidence of fetal acidosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Anesthesia Problems
Keywords
Anesthesia, Obstetric, fluid therapy, cesarean section, spinal anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal-directed preloading
Arm Type
Experimental
Arm Description
Fluid 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%
Arm Title
Preloading
Arm Type
Active Comparator
Arm Description
Fluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml "Ringer's injection" with a pressurizer within 15 minutes.
Intervention Type
Drug
Intervention Name(s)
Fluid therapy
Other Intervention Name(s)
"Ringer's Injection"
Intervention Description
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%
Intervention Type
Procedure
Intervention Name(s)
Spinal anaesthesia
Intervention Description
Inject marcaine and fentanyl to CSF for anaesthesia
Primary Outcome Measure Information:
Title
Incidence of maternal hypotension
Time Frame
delivery
Secondary Outcome Measure Information:
Title
Dosage of vasopressor
Time Frame
delivery
Title
Total fluid volume
Time Frame
delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 20-45 y/o parturient Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo cesarean section Exclusion criteria: Emergent C/S BMI>35kg/m2 Height <150cm or >175 cm Patients with major cardiovascular disease, preeclampsia or eclampsia. Gestational age < 36wks Multiple pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YiShiuan Lin
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NTUH
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33855080
Citation
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.
Results Reference
derived

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Preloading to Prevent Hypotension During Cesarean Section

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