Effects of Crystal Solution and Colloid Solution on Mother and Fetus

Cesarean Section Clinical Trial

Official title:

Comparison of the Effects of Crystal Solution (Lactic Acid Ringer's Solution) and Colloid Solution (Hydroxyethyl Starch) on Mother and Fetus After Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432675
• Other study ID #: CINI-AD-20205-13
• Status: Completed
• Phase: Phase 4
• Start date: January 30, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: June 2020
• Source: China International Neuroscience Institution
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid solution (hydroxyethyl starch) on mother and fetus after cesarean section

Description:

The Hydroxyethl group use 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch. The control group 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution. During the whole operation of elective cesarean section

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy singleton pregnancy scheduled for elective cesarean section under CSEA; American Society of Anesthesiologists (ASA) physical status ?/?; Age ranging from 20 to 40 years old.

Exclusion Criteria:

• History of mental disorder or epilepsy; History of central nervous system (CNS) disease; Preexisting or pregnancy-induced hypertension; History of lumber injury; Severe hypovolemia; Allergy or hypersensitivity to norepinephrine; Body mass index (BMI) above 40 kg/m2; Infection at the puncture site; Tricyclic or imipramine antidepressants.

Related Conditions & MeSH terms

• Cesarean Section
• Parturition
• Spinal Anesthesia

Intervention

Drug:
• hydroxyethl starch
10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
• Lactated Ringer's solution
10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution

Locations

Country	Name	City	State
China	Xuanwu hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China International Neuroscience Institution

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypotension	The incidence of maternal hypotension during the operation	during operation procedure
Secondary	umbilical vein blood gases	umbilical vein blood gases	24 hours
Secondary	umbilical artery blood gases	umbilical artery blood gases	24 hours
Secondary	Maternal vein blood gase	Maternal vein blood gase	24 hours
Secondary	The incidences of maternal complications	The incidences of maternal complications such as hypotension, tachycardia, bandycardia, nausea and vomiting, breath difficulty, and dizzy perioperatively.	24 hours
Secondary	Hemodynamic data at time point	Hemodynamic data at time point	24 hours