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Completed

NCT Number: NCT04432675

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

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Key information

Conditions

Cesarean Section Parturition Spinal Anesthesia

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hydroxyethl starch

Drug

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

Lactated Ringer's solution

Drug

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

Primary outcomes

  1. hypotension

    Time frame: during operation procedure

    The incidence of maternal hypotension during the operation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

China International Neuroscience Institution

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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