Obstetric Anesthesia ProblemsNCT03013140
Preloading to Prevent Hypotension During Cesarean Section
A study testing Fluid therapy and Spinal anaesthesia in people with Obstetric Anesthesia Problems, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in caesarean section can effectively reduce the incidence of hypotension and fetal complications. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anesthesia Problems
- What is being tested?
- Fluid therapy and Spinal anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Feb 2017to 9 Jun 2019
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-45 y/o parturient
- Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo cesarean section
Who cannot join
- Emergent C/S
- BMI>35kg/m2
- Height <150cm or >175 cm
- Patients with major cardiovascular disease, preeclampsia or eclampsia.
- Gestational age < 36wks
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-optimization of Fluid Status to Prevent Hypotension by Non-invasive Arterial Pressure Monitor During Cesarean Section
Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in caesarean section can effectively reduce the incidence of hypotension and fetal complications.
Read the detailed description
Spinal anesthesia in the cesarean section often causes significant peripheral vascular dilatation, decreases blood pressure and cardiac output reduction which leads to maternal nausea, vomiting, dizziness and uteroplacental hypoperfusion. Infusion therapy and the use of vasopressor can prevent and treat the incidence of hypotension. Appropriate fluid therapy can not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. In the present study, perioperative goal directed fluid therapy is used. The non-invasive continuous hemodynamic monitor is used in this study, and the parameters (blood pressure (BP), stroke volume(SV), stroke volume variation (SVV), cardiac output (CO)) are used to determine the parameters of the blood transfusion in cesarean section as infusion guidelines. The application of Clearsight system to the pre-infusion of target-guided crystalloid solution is compared with the infusion of quantitative crystalline solution in the hope of reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving uteroplacental perfusion and reducing the incidence of fetal acidosis.
- Conditions
- Obstetric Anesthesia Problems
- Being tested
- Fluid therapy, Spinal anaesthesia
- Keywords
- Anesthesia, Obstetric, fluid therapy, cesarean section, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid therapyDrug
Also called "Ringer's Injection"
Goal directed Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat "Ringer's Injection" 3ml/kg within 3 minutes with 1-min gap until ΔSV<5%
Spinal anaesthesiaProcedure or surgery
Inject marcaine and fentanyl to CSF for anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Goal-directed preloading | Experimental | Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat "Ringer's Injection" 3ml/kg within 3 minutes with 1-min gap until change in SV (ΔSV) <5% Receives: Drug: Fluid therapy; Procedure: Spinal anaesthesia |
| Preloading | Active comparator | Fluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml "Ringer's injection" with a pressurizer within 15 minutes. Receives: Procedure: Spinal anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of maternal hypotension
Measured: delivery
Secondary outcomes (2)
Dosage of vasopressor
Measured: delivery
Total fluid volume
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start3 Feb 2017
- Primary completion29 Nov 2018
- Study completion9 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric Anesthesia ProblemsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YiShiuan Lin, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013140
- Sponsor's protocol ID
- 201610025RIND
- Status last verified
- Jul 2019
- First submitted
- 22 Dec 2016
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang SH, Lin YS, Lee CN, Cheng YJ, Chen YH, Chiu HC, Wu CY. Implications of Continuous Noninvasive Finger Cuff Arterial Pressure Device Use during Cesarean Delivery for Goal-Directed Fluid Therapy Preload Optimization: A Randomized Controlled Trial. Biomed Res Int. 2021 Mar 28;2021:6685584. doi: 10.1155/2021/6685584. eCollection 2021.
PubMed 33855080
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-optimization of Fluid Status to Prevent Hypotension by Non-invasive Arterial Pressure Monitor During Cesarean Section
- ClinicalTrials.gov ID
- NCT03013140
- Acronym / sponsor ID
- 201610025RIND
- Conditions
- Obstetric Anesthesia Problems
- Keywords
- Anesthesia, Obstetric, fluid therapy, cesarean section, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 9 Jun 2019 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in caesarean section can effectively reduce the incidence of hypotension and fetal complications.
Detailed description
Spinal anesthesia in the cesarean section often causes significant peripheral vascular dilatation, decreases blood pressure and cardiac output reduction which leads to maternal nausea, vomiting, dizziness and uteroplacental hypoperfusion. Infusion therapy and the use of vasopressor can prevent and treat the incidence of hypotension. Appropriate fluid therapy can not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. In the present study, perioperative goal directed fluid therapy is used. The non-invasive continuous hemodynamic monitor is used in this study, and the parameters (blood pressure (BP), stroke volume(SV), stroke volume variation (SVV), cardiac output (CO)) are used to determine the parameters of the blood transfusion in cesarean section as infusion guidelines. The application of Clearsight system to the pre-infusion of target-guided crystalloid solution is compared with the infusion of quantitative crystalline solution in the hope of reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving uteroplacental perfusion and reducing the incidence of fetal acidosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-directed preloading | Experimental | Drug: Fluid therapy, Procedure: Spinal anaesthesiaFluid therapy: Within 30 minutes before spinal anaesthesia, repeat "Ringer's Injection" 3ml/kg within 3 minutes with 1-min gap until change in SV (ΔSV) <5% |
| Preloading | Active comparator | Procedure: Spinal anaesthesiaFluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml "Ringer's injection" with a pressurizer within 15 minutes. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20-45 y/o parturient
- Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo cesarean section
Key exclusion criteria (6 listed)
- Emergent C/S
- BMI>35kg/m2
- Height <150cm or >175 cm
- Patients with major cardiovascular disease, preeclampsia or eclampsia.
- Gestational age < 36wks
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 |
|---|---|---|
| Fluid therapyAlso: "Ringer's Injection"Goal directed Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat "Ringer's Injection" 3ml/kg within 3 minutes with 1-min gap until ΔSV<5% | Drug | Goal-directed preloading |
| Spinal anaesthesiaInject marcaine and fentanyl to CSF for anaesthesia | Procedure or surgery | Goal-directed preloading, Preloading |
Primary outcome
Incidence of maternal hypotension
Time frame: delivery
2 secondary outcomes
Dosage of vasopressor
Time frame: delivery
Total fluid volume
Time frame: delivery
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 9 Jan 2020.
- Derived from this study: PubMed 33855080Yang SH, Lin YS, Lee CN, Cheng YJ, Chen YH, Chiu HC, Wu CY. Implications of Continuous Noninvasive Finger Cuff Arterial Pressure Device Use during Cesarean Delivery for Goal-Directed Fluid Therapy Preload Optimization: A Randomized Controlled Trial. Biomed Res Int. 2021 Mar 28;2021:6685584. doi: 10.1155/2021/6685584. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Obstetric Anesthesia Problems
Not yet recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
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.
YiShiuan Lin principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid therapy and Spinal anaesthesia in people with Obstetric Anesthesia Problems, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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 9 Jan 2020. 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 Taiwan. 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.
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?
Incidence of maternal hypotension (time frame: delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03013140, which also lists 1 linked publication.
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 9 Jan 2020.