Effects of Crystal Solution and Colloid Solution on Mother and Fetus

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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Spinal Anesthesia; Parturition
• Intervention / Treatment: Drug: hydroxyethl starch; Drug: Lactated Ringer's solution

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy singleton pregnancy scheduled for elective cesarean section under CSEA; American Society of Anesthesiologists (ASA) physical status Ⅰ/Ⅱ; 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: hydroxyethl starch group; 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch	Drug: hydroxyethl starch; 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch; Other Names: Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection
ACTIVE_COMPARATOR: The control group; 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypotension	The incidence of maternal hypotension during the operation	during operation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
umbilical vein blood gases	umbilical vein blood gases	24 hours
umbilical artery blood gases	umbilical artery blood gases	24 hours
Maternal vein blood gase	Maternal vein blood gase	24 hours
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
Hemodynamic data at time point	Hemodynamic data at time point	24 hours

Collaborators and Investigators

• Sponsor: China International Neuroscience Institution
• Investigators: Study Chair: Yanghai Cui, China International Neuroscience Institution

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2022
• Primary Completion (ACTUAL): November 15, 2022
• Study Completion (ACTUAL): November 15, 2022

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 13, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CINI-AD-20205-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No