Preloading to Prevent Hypotension During Cesarean Section

Pre-optimization of Fluid Status to Prevent Hypotension by Non-invasive Arterial Pressure Monitor During Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Obstetric Anesthesia Problems
• Intervention / Treatment: Drug: Fluid therapy; Procedure: Spinal anaesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • NTUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Goal-directed preloading; 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%	Drug: Fluid therapy; 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%; Other Names: "Ringer's Injection"; Procedure: Spinal anaesthesia; Inject marcaine and fentanyl to CSF for anaesthesia
ACTIVE_COMPARATOR: Preloading; Fluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml "Ringer's injection" with a pressurizer within 15 minutes.	Procedure: Spinal anaesthesia; Inject marcaine and fentanyl to CSF for anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of maternal hypotension	delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Dosage of vasopressor	delivery
Total fluid volume	delivery

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: YiShiuan Lin, National Taiwan University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 3, 2017
• Primary Completion (ACTUAL): November 29, 2018
• Study Completion (ACTUAL): June 9, 2019

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (ESTIMATE): January 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: cesarean section; spinal anesthesia; fluid therapy; Anesthesia, Obstetric
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 201610025RIND

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