Clinical trial NCT03013140: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Anesthesia Problems
Keywords: Anesthesia, Obstetric
fluid therapy
cesarean section
spinal anesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 71
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of maternal hypotension
timeFrame: delivery
Secondary outcomes:
measure: Dosage of vasopressor
timeFrame: delivery
measure: Total fluid volume
timeFrame: delivery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: National Taiwan University Hospital
name: YiShiuan Lin
role: PRINCIPAL_INVESTIGATOR
References:
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.