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Effects of Crystal Solution and Colloid Solution on Mother and Fetus

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ClinicalTrials.gov Identifier: NCT04432675
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
China International Neuroscience Institution

Brief 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

Condition or disease Intervention/treatment Phase
Cesarean Section Spinal Anesthesia Parturition Drug: hydroxyethl starch Drug: Lactated Ringer's solution Phase 4

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Starch

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 Name: 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




Primary Outcome Measures :
  1. hypotension [ Time Frame: during operation procedure ]
    The incidence of maternal hypotension during the operation


Secondary Outcome Measures :
  1. umbilical vein blood gases [ Time Frame: 24 hours ]
    umbilical vein blood gases

  2. umbilical artery blood gases [ Time Frame: 24 hours ]
    umbilical artery blood gases

  3. Maternal vein blood gase [ Time Frame: 24 hours ]
    Maternal vein blood gase

  4. The incidences of maternal complications [ Time Frame: 24 hours ]
    The incidences of maternal complications such as hypotension, tachycardia, bandycardia, nausea and vomiting, breath difficulty, and dizzy perioperatively.

  5. Hemodynamic data at time point [ Time Frame: 24 hours ]
    Hemodynamic data at time point



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432675


Contacts
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Contact: Yanghai Cui, PHD 83199270 ext 83199270 1055885750@qq.com

Sponsors and Collaborators
China International Neuroscience Institution
Investigators
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Study Chair: Yanghai Cui China International Neuroscience Institution
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Responsible Party: China International Neuroscience Institution
ClinicalTrials.gov Identifier: NCT04432675    
Other Study ID Numbers: CINI-AD-20205-13
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No