Cesarean SectionPhase 4NCT04432675
Effects of Crystal Solution and Colloid Solution on Mother and Fetus
A Phase 4 study testing hydroxyethl starch and Lactated Ringer's solution in people with Cesarean Section and Spinal Anesthesia, run by China International Neuroscience Institution at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Spinal Anesthesia, Parturition
- What is being tested?
- hydroxyethl starch and Lactated Ringer's solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2022to 15 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Cesarean Section, Spinal Anesthesia, Parturition
- Being tested
- hydroxyethl starch, Lactated Ringer's solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyethl starchDrug
Also called Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection
10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
Lactated Ringer's solutionDrug
10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
| Study group | Role | What they receive |
|---|---|---|
| hydroxyethl starch group | Experimental | 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch Receives: Drug: hydroxyethl starch |
| The control group | Active comparator | 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution Receives: Drug: Lactated Ringer's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypotension
The incidence of maternal hypotension during the operation
Measured: during operation procedure
Secondary outcomes (5)
umbilical vein blood gases
umbilical vein blood gases
Measured: 24 hours
umbilical artery blood gases
umbilical artery blood gases
Measured: 24 hours
Maternal vein blood gase
Maternal vein blood gase
Measured: 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.
Measured: 24 hours
Hemodynamic data at time point
Hemodynamic data at time point
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start30 Jan 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanghai Cui, Study chair, China International Neuroscience Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432675
- Sponsor's protocol ID
- CINI-AD-20205-13
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04432675
- Acronym / sponsor ID
- CINI-AD-20205-13
- Conditions
- Cesarean Section, Spinal Anesthesia, Parturition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid solution (hydroxyethyl starch) on mother and fetus after cesarean section
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydroxyethl starch group | Experimental | Drug: hydroxyethl starch10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch |
| The control group | Active comparator | Drug: Lactated Ringer's solution10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxyethl starchAlso: Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch | Drug | hydroxyethl starch group |
| Lactated Ringer's solution10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution | Drug | The control group |
Primary outcome
hypotension
Time frame: during operation procedure
The incidence of maternal hypotension during the operation
5 secondary outcomes
umbilical vein blood gases
Time frame: 24 hours
umbilical artery blood gases
Time frame: 24 hours
Maternal vein blood gase
Time frame: 24 hours
The incidences of maternal complications
Time frame: 24 hours
Hemodynamic data at time point
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
Related trials for Cesarean Section
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Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
Recovery of Function, Postoperative Period
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Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
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Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanghai Cui study chair
China International Neuroscience Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hydroxyethl starch and Lactated Ringer's solution in people with Cesarean Section and Spinal Anesthesia, run by China International Neuroscience Institution at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypotension (time frame: during operation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.