Cesarean SectionPhase 4NCT03764202
Determination of Sufentanil in Breast Milk of Puerpera
A Phase 4 study testing Detection of sufentanil concentration in people with Cesarean Section, run by Fujian Medical University Union Hospital.
Trial summary
To determination of sufentanil in human breast milk during the administration of the sufentanil via the analgesic infusion pump and after the administration, to determine whether the breastfeeding after clinical anesthetic or analgesic administration has an effect on the infant and provide a reference for the security… Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Detection of sufentanil concentration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2017
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 20yr to 38yr
- Height 155~170 cm
- Weight 65~85 Kg
- American Society of Anesthesiologists statuses I or II
- Normal cardiac and pulmonary function
- Undergoing elective Cesarean section
- Willing to provide breast milk
Who cannot join
- pregnancy induced hypertension
- gestational diabetes
- gestational heart disease
About this study
Official title: Determination of Sufentanil in Breast Milk of Puerpera During Analgesia
To determination of sufentanil in human breast milk during the administration of the sufentanil via the analgesic infusion pump and after the administration, to determine whether the breastfeeding after clinical anesthetic or analgesic administration has an effect on the infant and provide a reference for the security issues.
Read the detailed description
The concentration of sufentanil in milk was determined by LC-MS /MS method( liquid chromatography mass spectrometry).The separation was carried on Agilent ZORBAX Eclipse Plus C18 column(2.1×50 mm, 3.5 μm)with a mobile phase of 10 mmol ammonium formate(A)and methanol(B), and the elution conditions were optimized as follows：linear gradient 0→0.30 min, A:B=50:50; 0.30→0.31 min, A:B=50:50→10:90; 3.00→3.10 min, A:B=10:90→50:50; 3.1→6.5min, A:B=50:50; The flowing rate was 0.2 mL•min-1, column temperature was 30 ℃, injection volume was 5 μL. ESI source was applied and operated in positive ion mode. Quantitative determination was performed using multiple reaction monitoring (MRM) of m/z 387.2 → m/z 238.2 for sufentanil, and m/z 337.2 → m/z 158.2 for fentanyl.
- Conditions
- Cesarean Section
- Being tested
- Detection of sufentanil concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of sufentanil concentrationOther
- Concentration of sufentanil in human breast milk was determined by LC-MS /MS method
- The volume of human breast milk was detected at each fixed time point
| Study group | Role | What they receive |
|---|---|---|
| CSEA，1μg/kg•d | Other | * The puerpera received combined spinal epidural anesthesia
* The dosage of sufentanil intravenous analgesia was 1 μg/kg•d Receives: Other: Detection of sufentanil concentration |
| CSEA，1.5μg/kg•d | Other | * The puerpera received combined spinal epidural anesthesia
* The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d Receives: Other: Detection of sufentanil concentration |
| GA，1μg/kg•d | Other | * The puerpera received general anesthesia
* The dosage of sufentanil intravenous analgesia was 1 μg/kg•d Receives: Other: Detection of sufentanil concentration |
| GA，1.5μg/kg•d | Other | * The puerpera received general anesthesia
* The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d Receives: Other: Detection of sufentanil concentration |
| CSEA，Epidural analgesia | Other | * The puerpera received combined spinal epidural anesthesia
* Postoperative analgesia was performed with epidural analgesia
* Speed of epidural analgesia pump ：6ml/h（0.1% ropivacaine , 0.5μg/ml sufentanil） Receives: Other: Detection of sufentanil concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of sufentanil in human breast milk
The concentration of sufentanil in human breast milk was detected at each fixed time point
Measured: 1 year
The volume of human breast milk
The volume of human breast milk was detected at each fixed time point
Measured: 1 year
The dose of sufentanil in human breast milk
The amount of sufentanil in the milk multiplied by the concentration of sufentanil and the volume of milk at each fixed time point
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study startAug 2015
- Primary completionOct 2017
- Study completionDec 2017
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.
- More trials run by Fujian Medical University Union 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang liangcheng, M.D., Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764202
- Sponsor's protocol ID
- WUWQNXM 2015-1-36
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Sufentanil in Breast Milk of Puerpera During Analgesia
- ClinicalTrials.gov ID
- NCT03764202
- Acronym / sponsor ID
- WUWQNXM 2015-1-36
- Conditions
- Cesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Dec 2018 (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.
To determination of sufentanil in human breast milk during the administration of the sufentanil via the analgesic infusion pump and after the administration, to determine whether the breastfeeding after clinical anesthetic or analgesic administration has an effect on the infant and provide a reference for the security issues.
Detailed description
The concentration of sufentanil in milk was determined by LC-MS /MS method( liquid chromatography mass spectrometry).The separation was carried on Agilent ZORBAX Eclipse Plus C18 column(2.1×50 mm, 3.5 μm)with a mobile phase of 10 mmol ammonium formate(A)and methanol(B), and the elution conditions were optimized as follows：linear gradient 0→0.30 min, A:B=50:50; 0.30→0.31 min, A:B=50:50→10:90; 3.00→3.10 min, A:B=10:90→50:50; 3.1→6.5min, A:B=50:50; The flowing rate was 0.2 mL•min-1, column temperature was 30 ℃, injection volume was 5 μL. ESI source was applied and operated in positive ion mode. Quantitative determination was performed using multiple reaction monitoring (MRM) of m/z 387.2 → m/z 238.2 for sufentanil, and m/z 337.2 → m/z 158.2 for fentanyl.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CSEA，1μg/kg•d | Other | Other: Detection of sufentanil concentration* The puerpera received combined spinal epidural anesthesia * The dosage of sufentanil intravenous analgesia was 1 μg/kg•d |
| CSEA，1.5μg/kg•d | Other | Other: Detection of sufentanil concentration* The puerpera received combined spinal epidural anesthesia * The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d |
| GA，1μg/kg•d | Other | Other: Detection of sufentanil concentration* The puerpera received general anesthesia * The dosage of sufentanil intravenous analgesia was 1 μg/kg•d |
| GA，1.5μg/kg•d | Other | Other: Detection of sufentanil concentration* The puerpera received general anesthesia * The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d |
| CSEA，Epidural analgesia | Other | Other: Detection of sufentanil concentration* The puerpera received combined spinal epidural anesthesia * Postoperative analgesia was performed with epidural analgesia * Speed of epidural analgesia pump ：6ml/h（0.1% ropivacaine , 0.5μg/ml sufentanil） |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 20yr to 38yr
- Height 155~170 cm
- Weight 65~85 Kg
- American Society of Anesthesiologists statuses I or II
- Normal cardiac and pulmonary function
Key exclusion criteria (3 listed)
- pregnancy induced hypertension
- gestational diabetes
- gestational heart disease
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 |
|---|---|---|
| Detection of sufentanil concentration* Concentration of sufentanil in human breast milk was determined by LC-MS /MS method * The volume of human breast milk was detected at each fixed time point | Other | CSEA，1.5μg/kg•d, CSEA，1μg/kg•d, CSEA，Epidural analgesia, GA，1.5μg/kg•d, GA，1μg/kg•d |
Primary outcome
The concentration of sufentanil in human breast milk
Time frame: 1 year
The concentration of sufentanil in human breast milk was detected at each fixed time point
The volume of human breast milk
Time frame: 1 year
The volume of human breast milk was detected at each fixed time point
The dose of sufentanil in human breast milk
Time frame: 1 year
The amount of sufentanil in the milk multiplied by the concentration of sufentanil and the volume of milk at each fixed time point
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 5 Dec 2018.
Related trials for Cesarean Section
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
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
Zhang liangcheng, M.D. principal investigator
Fujian Medical University Union Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Detection of sufentanil concentration in people with Cesarean Section, run by Fujian Medical University Union Hospital.
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 7 inclusion and 3 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The concentration of sufentanil in human breast milk (time frame: 1 year). The study lists 3 primary outcomes in all. 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 5 Dec 2018.