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
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
January 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2022
CompletedDecember 1, 2022
June 1, 2020
10 months
June 5, 2020
November 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
hypotension
The incidence of maternal hypotension during the operation
during operation procedure
Secondary Outcomes (5)
umbilical vein blood gases
24 hours
umbilical artery blood gases
24 hours
Maternal vein blood gase
24 hours
The incidences of maternal complications
24 hours
Hemodynamic data at time point
24 hours
Study Arms (2)
hydroxyethl starch group
EXPERIMENTAL10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
The control group
ACTIVE COMPARATOR10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
Interventions
10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuanwu hospital
Beijing, Beijing Municipality, 100053, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yanghai Cui
China International Neuroscience Institution
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
June 16, 2020
Study Start
January 30, 2022
Primary Completion
November 15, 2022
Study Completion
November 15, 2022
Last Updated
December 1, 2022
Record last verified: 2020-06