Preloading to Prevent Hypotension During Cesarean Section

Obstetric Anesthesia Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013140
• Other study ID #: 201610025RIND
• Status: Completed
• Phase: N/A
• Start date: February 3, 2017
• Est. completion date: June 9, 2019

Study information

• Verified date: July 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 9, 2019
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Obstetric Anesthesia Problems

Intervention

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 ?SV<5%

Procedure:
• Spinal anaesthesia
Inject marcaine and fentanyl to CSF for anaesthesia

Locations

Country	Name	City	State
Taiwan	NTUH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of maternal hypotension		delivery
Secondary	Dosage of vasopressor		delivery
Secondary	Total fluid volume		delivery