Preloading to Prevent Hypotension During Cesarean Section

Not Applicable

Completed

• Conditions: Obstetric Anesthesia Problems
• Interventions: Drug: Fluid therapy; Procedure: Spinal anaesthesia

• Registration Number: NCT03013140
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Study Start: 2017-02-03
• Primary Completion: 2018-11-29
• Study Completion: 2019-06-09
• Status Verified: 2019-07
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal-directed preloading	Fluid therapy	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%
Goal-directed preloading	Spinal anaesthesia	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%
Preloading	Spinal anaesthesia	Fluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml "Ringer's injection" with a pressurizer within 15 minutes.

Primary Outcome Measures

Name	Time	Method
Incidence of maternal hypotension	delivery

Secondary Outcome Measures

Name	Time	Method
Dosage of vasopressor	delivery
Total fluid volume	delivery

Trial Locations

Locations (1)

NTUH; 🇨🇳 Taipei, Taiwan