Cesarean Section ComplicationsPhase 2/3NCT03833895
The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section
A Phase 2/3 study testing Norepinephrine, Phenylephrine and Ringer's Solution in people with Cesarean Section Complications, run by China International Neuroscience Institution at 1 site in China.
Trial summary
Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and parturient during Cesarean Section Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Norepinephrine, Phenylephrine and Ringer's Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2019to 2 Sep 2019
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- a healthy singleton pregnancy scheduled for elective cesarean delivery (CD) under combined spinal-epidural anesthesia (CSEA),
- American Society of Anesthesiologists (ASA) physical status I/II
- 20 to 40 years old
Who cannot join
- history of mental disorder or epilepsy,
- tricyclic or imipramine antidepressant use,
- central nervous system (CNS) disease,
- preexisting or pregnancy-induced hypertension,
- lumbar injury,
- severe hypovolemia,
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- allergy
- history of hypersensitivity to vasopressor
- body mass index (BMI) >40 kg/m2,
- infection at the puncture site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Phenylephrine vs. Norepinephrine Infusion by Lidico Monitoring With Pregnancy Patients Undergoing Cesarean Section
Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and parturient during Cesarean Section
Read the detailed description
- Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on parturient hemodynamic change (systolic blood pressure SBP, diastolic blood pressure DBP,mean arterial pressure MAP,heart rate HR) and on LIDICO-rapid monitoring ( stroke volume SV, systemic vascular resistance SVR, cardiac output CO) and peripheral vein (PV) blood gas during Cesarean Section.
- Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on fetus by blood gas of the umbilical vein (UV), umbilical artery (UA),
- Conditions
- Cesarean Section Complications
- Being tested
- Norepinephrine, Phenylephrine, Ringer's Solution
- Keywords
- Cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Group 1 Elements
0.05ug/kg/min Norepinephrine during Cesarean Section Operation
PhenylephrineDrug
Also called Group 2 Elements
0.25ug/kg/min phenylephrine during Cesarean Section Operation
Ringer's SolutionDrug
Also called Group 3 Elements
3 ml/kg/min of LR was administrated according to standard weight.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Elements | Experimental | Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation Receives: Drug: Norepinephrine |
| Group 2 Elements | Experimental | Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation Receives: Drug: Phenylephrine |
| Group 3 Elements | Placebo comparator | In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight. Receives: Drug: Ringer's Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring
Systolic blood pressure (SBP)
Measured: through study completion, an average of 24 hour
Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring
Diastolic blood pressure (DBP)
Measured: Through study completion
Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring
Mean arterial pressure (MAP)
Measured: An average of 24 hour
Heart rate (HR) change as the one of hemodynamic outcome in general monitoring
Heart rate (HR)
Measured: Through the study completion, an average of 24 hour
Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient
Stroke volume (SV)
Measured: Through study completion, an average of 24 hour
Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient
Cardiac output (CO)
Measured: Through study completion, an average of 24 hour
Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturient
Systemic vascular resistance (SVR)
Measured: Through study completion, an average of 24 hour
Secondary outcomes (3)
The benefits to the fetus based on umbilical vein (UV) blood gas
The umbilical vein (UV) blood gas
Measured: Through study completion, an average of 24 hour
The benefits to the fetus based on umbilical artery (UA) blood gas
The umbilical artery (UA) blood gas
Measured: Through study completion, an average of 24 hour
The benefits to parturient based on peripheral vein (PV) blood gas
Peripheral vein (PV) blood gas
Measured: Through study completion, an average of 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start20 Feb 2019
- Primary completion1 Sep 2019
- Study completion2 Sep 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 Cesarean Section ComplicationsStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tianlong Wang, MD,PHD, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833895
- Sponsor's protocol ID
- CINI-AD-201812-3
- Status last verified
- Feb 2020
- First submitted
- 20 Jan 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feng K, Wang X, Feng X, Zhang J, Xiao W, Wang F, Zhou Q, Wang T. Effects of continuous infusion of phenylephrine vs. norepinephrine on parturients and fetuses under LiDCOrapid monitoring: a randomized, double-blind, placebo-controlled study. BMC Anesthesiol. 2020 Sep 7;20(1):229. doi: 10.1186/s12871-020-01145-0.
PubMed 32894044
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phenylephrine vs. Norepinephrine Infusion by Lidico Monitoring With Pregnancy Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT03833895
- Acronym / sponsor ID
- CINI-AD-201812-3
- Conditions
- Cesarean Section Complications
- Keywords
- Cesarean delivery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 7 Feb 2019 (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.
Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and parturient during Cesarean Section
Detailed description
- Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on parturient hemodynamic change (systolic blood pressure SBP, diastolic blood pressure DBP,mean arterial pressure MAP,heart rate HR) and on LIDICO-rapid monitoring ( stroke volume SV, systemic vascular resistance SVR, cardiac output CO) and peripheral vein (PV) blood gas during Cesarean Section.
- Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on fetus by blood gas of the umbilical vein (UV), umbilical artery (UA),
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Elements | Experimental | Drug: NorepinephrineContinuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation |
| Group 2 Elements | Experimental | Drug: PhenylephrineContinuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation |
| Group 3 Elements | Placebo comparator | Drug: Ringer's SolutionIn the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- a healthy singleton pregnancy scheduled for elective cesarean delivery (CD) under combined spinal-epidural anesthesia (CSEA),
- American Society of Anesthesiologists (ASA) physical status I/II
- 20 to 40 years old
Key exclusion criteria (10 listed)
- history of mental disorder or epilepsy,
- tricyclic or imipramine antidepressant use,
- central nervous system (CNS) disease,
- preexisting or pregnancy-induced hypertension,
- lumbar injury,
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 |
|---|---|---|
| NorepinephrineAlso: Group 1 Elements0.05ug/kg/min Norepinephrine during Cesarean Section Operation | Drug | Group 1 Elements |
| PhenylephrineAlso: Group 2 Elements0.25ug/kg/min phenylephrine during Cesarean Section Operation | Drug | Group 2 Elements |
| Ringer's SolutionAlso: Group 3 Elements3 ml/kg/min of LR was administrated according to standard weight. | Drug | Group 3 Elements |
Primary outcome
Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring
Time frame: through study completion, an average of 24 hour
Systolic blood pressure (SBP)
Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring
Time frame: Through study completion
Diastolic blood pressure (DBP)
Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring
Time frame: An average of 24 hour
Mean arterial pressure (MAP)
Heart rate (HR) change as the one of hemodynamic outcome in general monitoring
Time frame: Through the study completion, an average of 24 hour
Heart rate (HR)
Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient
Time frame: Through study completion, an average of 24 hour
Stroke volume (SV)
Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient
Time frame: Through study completion, an average of 24 hour
Cardiac output (CO)
Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturient
Time frame: Through study completion, an average of 24 hour
Systemic vascular resistance (SVR)
3 secondary outcomes
The benefits to the fetus based on umbilical vein (UV) blood gas
Time frame: Through study completion, an average of 24 hour
The benefits to the fetus based on umbilical artery (UA) blood gas
Time frame: Through study completion, an average of 24 hour
The benefits to parturient based on peripheral vein (PV) blood gas
Time frame: Through study completion, an average of 24 hour
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 10 Feb 2020.
- Derived from this study: PubMed 32894044Feng K, Wang X, Feng X, Zhang J, Xiao W, Wang F, Zhou Q, Wang T. Effects of continuous infusion of phenylephrine vs. norepinephrine on parturients and fetuses under LiDCOrapid monitoring: a randomized, double-blind, placebo-controlled study. BMC Anesthesiol. 2020 Sep 7;20(1):229. doi: 10.1186/s12871-020-01145-0.
- Individual participant dataSharing planned: No
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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.
Tianlong Wang, MD,PHD study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Norepinephrine, Phenylephrine and Ringer's Solution in people with Cesarean Section Complications, 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 3 inclusion and 10 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 10 Feb 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring (time frame: through study completion, an average of 24 hour). The study lists 7 primary outcomes in all. 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 NCT03833895, 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 10 Feb 2020.