Cesarean Section ComplicationsPhase 4NCT04991662
Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery
A Phase 4 study testing metaraminol, Phenylephrine and Norepinephrine in people with Cesarean Section Complications, run by Xuzhou Medical University at 1 site in China.
Trial summary
This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- metaraminol, Phenylephrine and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2021to 3 Dec 2021
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery;
- height 150-180 cm;
- American Society of Anesthesiologists (ASA) physical status II-III;
- body mass index (BMI) <35 kg/m2.
Who cannot join
- transverse presentation, fetal macrosomia;
- uterine abnormalities (eg, large fibroids, bicornuate uterus);
- polyhydramnios;
- ruptured membranes, oligohydramnios;
- intrauterine growth restriction;
- gestational or nongestational hypertension, diabetes, or eclampsia;
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- hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for >10 years) or renal failure;
- contraindications for combined spinal-epidural anesthesia;
- participants who declined to sign informed consent forms.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology and Operating Room, Affiliated Hospital of Peking University People's Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: Effect of Three Weight-adjusted Vasopressors for With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial
This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics.
Read the detailed description
At present, the ED90 of metaraminol, phenylephrine, and norepinephrine in the prevention of cesarean section hypotension has been explored. We compare the effects of three drugs on the fetus and mothers at the concentration of ED90 to provide advice on the use of vasoactive drugs for obstetrics anesthesia .
- Conditions
- Cesarean Section Complications
- Being tested
- metaraminol, Phenylephrine, Norepinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metaraminolDrug
Also called M group
Infusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.
PhenylephrineDrug
Also called P group
Infusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.
NorepinephrineDrug
Also called N group
Infusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.
| Study group | Role | What they receive |
|---|---|---|
| metaraminol group | Experimental | During the cesarean section, metaraminol 2ug/kg/min is preventively infused after anesthesia to prevent and treat hypotension. Receives: Drug: metaraminol |
| phenylephrine group | Experimental | During cesarean section, preventive infusion of phenylephrine 0.54ug/kg/min after anesthesia to prevent and treat hypotension. Receives: Drug: Phenylephrine |
| norepinephrine group | Experimental | During cesarean section, preventive infusion of norepinephrine 0.08ug/kg/min after anesthesia to prevent and treat hypotension. Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical artery blood pH
pH value of fetal umbilical artery blood
Measured: 30 seconds after delivery
Secondary outcomes (5)
hypotension
Number of Participants with systolic blood pressure reduction >20% baseline value or systolic blood pressure <90 mm Hg before delivery
Measured: Intraoperative
bradycardia
Number of Participants with heart rate was ≤50 bpm before delivery
Measured: Intraoperative
The incidence of nausea in pregnant women
Anesthesiologist observes combined patient dictation.
Measured: Intraoperative
Umbilical artery blood base excess
base excess of fetal umbilical artery blood
Measured: 30sec after delivery
The incidence of vomiting in pregnant women
Anesthesiologist observes combined patient dictation
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start10 Oct 2021
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Xu, Xuzhou Medical University
- Investigators
- Feng Yi, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991662
- Sponsor's protocol ID
- SFY2021-HZ08-11
- Status last verified
- Sep 2021
- First submitted
- 9 Jun 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three Weight-adjusted Vasopressors for With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04991662
- Acronym / sponsor ID
- SFY2021-HZ08-11
- Conditions
- Cesarean Section Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 5 Aug 2021 (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.
This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics.
Detailed description
At present, the ED90 of metaraminol, phenylephrine, and norepinephrine in the prevention of cesarean section hypotension has been explored. We compare the effects of three drugs on the fetus and mothers at the concentration of ED90 to provide advice on the use of vasoactive drugs for obstetrics anesthesia .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| metaraminol group | Experimental | Drug: metaraminolDuring the cesarean section, metaraminol 2ug/kg/min is preventively infused after anesthesia to prevent and treat hypotension. |
| phenylephrine group | Experimental | Drug: PhenylephrineDuring cesarean section, preventive infusion of phenylephrine 0.54ug/kg/min after anesthesia to prevent and treat hypotension. |
| norepinephrine group | Experimental | Drug: NorepinephrineDuring cesarean section, preventive infusion of norepinephrine 0.08ug/kg/min after anesthesia to prevent and treat hypotension. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery;
- height 150-180 cm;
- American Society of Anesthesiologists (ASA) physical status II-III;
- body mass index (BMI) <35 kg/m2.
Key exclusion criteria (9 listed)
- transverse presentation, fetal macrosomia;
- uterine abnormalities (eg, large fibroids, bicornuate uterus);
- polyhydramnios;
- ruptured membranes, oligohydramnios;
- intrauterine growth restriction;
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 |
|---|---|---|
| metaraminolAlso: M groupInfusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood. | Drug | metaraminol group |
| PhenylephrineAlso: P groupInfusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood. | Drug | phenylephrine group |
| NorepinephrineAlso: N groupInfusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood. | Drug | norepinephrine group |
Primary outcome
Umbilical artery blood pH
Time frame: 30 seconds after delivery
pH value of fetal umbilical artery blood
5 secondary outcomes
hypotension
Time frame: Intraoperative
bradycardia
Time frame: Intraoperative
The incidence of nausea in pregnant women
Time frame: Intraoperative
Umbilical artery blood base excess
Time frame: 30sec after delivery
The incidence of vomiting in pregnant women
Time frame: Intraoperative
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 30 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Feng Yi, MD principal investigator
Peking University People's Hospital
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 metaraminol, Phenylephrine and Norepinephrine in people with Cesarean Section Complications, run by Xuzhou Medical University 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 4 inclusion and 9 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 30 Dec 2021. 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?
Umbilical artery blood pH (time frame: 30 seconds after delivery). 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 30 Dec 2021.