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CompletedNCT04432675Updated Dec 1, 2022

Effects of Crystal Solution and Colloid Solution on Mother and Fetus

A Phase 4 interventional study of hydroxyethl starch and Lactated Ringer's solution in Cesarean Section, Spinal Anesthesia and Parturition, sponsored by China International Neuroscience Institution. Completed at 1 site in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-12-01.

Sponsored by China International Neuroscience Institution · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
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Study 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

Read the 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

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Conditions studied

  • Cesarean Section
  • Spinal Anesthesia
  • Parturition
03

In context

Lead sponsor

China International Neuroscience Institution is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    hydroxyethl starch group

    10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch

    Drug: hydroxyethl starch

  • 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

Interventions

  • Drughydroxyethl starch

    10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch

    Also known as: Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection

  • DrugLactated Ringer's solution

    10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution

06

What researchers measure

Primary outcomes

  1. hypotension

    The incidence of maternal hypotension during the operation

    Time frame: during operation procedure

Secondary outcomes

  1. umbilical vein blood gases

    umbilical vein blood gases

    Time frame: 24 hours

  2. umbilical artery blood gases

    umbilical artery blood gases

    Time frame: 24 hours

  3. Maternal vein blood gase

    Maternal vein blood gase

    Time frame: 24 hours

  4. The incidences of maternal complications

    The incidences of maternal complications such as hypotension, tachycardia, bandycardia, nausea and vomiting, breath difficulty, and dizzy perioperatively.

    Time frame: 24 hours

  5. Hemodynamic data at time point

    Hemodynamic data at time point

    Time frame: 24 hours

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Study locations

1 site
  • Xuanwu hospital
    Beijing, Beijing 100053, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04432675
Lead sponsor
China International Neuroscience Institution
Responsible party
Sponsor
First posted
Jun 16, 2020
Start date
Jan 30, 2022
Primary completion
Nov 15, 2022
Completion
Nov 15, 2022
Last update
Dec 1, 2022

Study contacts

Yanghai Cui
study chair · China International Neuroscience Institution

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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