Amniotic Fluid EmbolismAOFAWTOOAFEIPUNCT06991985
Analysis of Factors Associated With The Occurrence of Amniotic Fluid Entry in Patients Undergoing Caesarean Section
An observational study of Amniotic Fluid Embolism, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial summary
To compare serum STN （Neuraminic acid-N-acetylgalactose）antigen concentrations in patients undergoing cesarean section and to study the factors associated with amniotic fluid entry.Compare the serum complement C4 concentration in patients in the amniotic fluid admission group with those in the non-admission group to… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amniotic Fluid Embolism
- What is being tested?
- Enzyme-linked immunosorbent assay
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients in the Second Hospital of Shanxi Medical University from May 2025 to November 2025
Who may be able to join
- Approved consent and informed consent of the patient by the Ethics Committee of the Second Hospital of Shanxi Medical University;
- ASA classification of I-III;
- Age 20-50 years old;
- No previous history of psychiatric diseases or psychotropic drugs;
Who cannot join
- Suffer from diseases of the cardiorespiratory system;
- Those with communication difficulties who were unable to complete the screening questionnaire;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
About this study
To compare serum STN （Neuraminic acid-N-acetylgalactose）antigen concentrations in patients undergoing cesarean section and to study the factors associated with amniotic fluid entry.Compare the serum complement C4 concentration in patients in the amniotic fluid admission group with those in the non-admission group to study whether amniotic fluid admission triggers the body's immune response.To record the patients' blood pressure, heart rate, blood oxygen, and the occurrence of related symptoms and adverse reactions at the time of admission, at the time of blood collection, at the time of discharge from the room, and at the time of the occurrence of haemodynamic changes.
Read the detailed description
All patients were routinely fasted for 8 h and abstained from drinking for 4 h. After entering the operating theatre, intravenous access was opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation and patient's symptoms were continuously monitored during the operation. After obtaining informed consent for anaesthesia from the patient and his family, intrathecal anaesthesia or general anaesthesia was administered according to the situation. Venous blood was drawn from the patient 30 min after the foetus was dissected out, and samples were preserved to measure the concentration of serum STN antigen and the concentration of complement C4; data were collected through the resident workstation system and the manual anaesthesia system, and the patient's information included age, history of allergy, number of deliveries, and history of combining with other illnesses; and the pregnancy information included Placenta type, amniotic fluid, hypertensive disorders of pregnancy, and whether or not the pregnancy was multiple; delivery data included whether or not elective caesarean section was performed, operator factors, intensity of contractions, method of rupture of membranes, and anaesthesia method.
- Conditions
- Amniotic Fluid Embolism
- Being tested
- Enzyme-linked immunosorbent assay
- Medical subject headings
- Embolism, Amniotic Fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme-linked immunosorbent assayDiagnostic test
Serum STN and C4 levels were detected
| Study group | Role | What they receive |
|---|---|---|
| Amniotic fluid into the blood group | Not described Receives: Diagnostic Test: Enzyme-linked immunosorbent assay | |
| the control group | Not described Receives: Diagnostic Test: Enzyme-linked immunosorbent assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
STN
Serum STN levels
Measured: 24 hours
C4
Serum C4 levels
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 posted28 May 2025
- Study start20 May 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic Fluid EmbolismStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991985
- Sponsor's protocol ID
- yuewei20250520
- Acronym
- AOFAWTOOAFEIPU
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Factors Associated With The Occurrence of Amniotic Fluid Entry in Patients Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT06991985
- Acronym / sponsor ID
- AOFAWTOOAFEIPU / yuewei20250520
- Conditions
- Amniotic Fluid Embolism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 May 2025 (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 compare serum STN （Neuraminic acid-N-acetylgalactose）antigen concentrations in patients undergoing cesarean section and to study the factors associated with amniotic fluid entry.Compare the serum complement C4 concentration in patients in the amniotic fluid admission group with those in the non-admission group to study whether amniotic fluid admission triggers the body's immune response.To record the patients' blood pressure, heart rate, blood oxygen, and the occurrence of related symptoms and adverse reactions at the time of admission, at the time of blood collection, at the time of discharge from the room, and at the time of the occurrence of haemodynamic changes.
Detailed description
All patients were routinely fasted for 8 h and abstained from drinking for 4 h. After entering the operating theatre, intravenous access was opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation and patient's symptoms were continuously monitored during the operation. After obtaining informed consent for anaesthesia from the patient and his family, intrathecal anaesthesia or general anaesthesia was administered according to the situation. Venous blood was drawn from the patient 30 min after the foetus was dissected out, and samples were preserved to measure the concentration of serum STN antigen and the concentration of complement C4; data were collected through the resident workstation system and the manual anaesthesia system, and the patient's information included age, history of allergy, number of deliveries, and history of combining with other illnesses; and the pregnancy information included Placenta type, amniotic fluid, hypertensive disorders of pregnancy, and whether or not the pregnancy was multiple; delivery data included whether or not elective caesarean section was performed, operator factors, intensity of contractions, method of rupture of membranes, and anaesthesia method.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic fluid into the blood group | – | Diagnostic Test: Enzyme-linked immunosorbent assay |
| the control group | – | Diagnostic Test: Enzyme-linked immunosorbent assay |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients in the Second Hospital of Shanxi Medical University from May 2025 to November 2025
Key inclusion criteria (4 listed)
- Approved consent and informed consent of the patient by the Ethics Committee of the Second Hospital of Shanxi Medical University;
- ASA classification of I-III;
- Age 20-50 years old;
- No previous history of psychiatric diseases or psychotropic drugs;
Key exclusion criteria (2 listed)
- Suffer from diseases of the cardiorespiratory system;
- Those with communication difficulties who were unable to complete the screening questionnaire;
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 |
|---|---|---|
| Enzyme-linked immunosorbent assaySerum STN and C4 levels were detected | Diagnostic test | Amniotic fluid into the blood group, the control group |
Primary outcome
STN
Time frame: 24 hours
Serum STN levels
C4
Time frame: 24 hours
Serum C4 levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
Related trials for Amniotic Fluid Embolism
RecruitingObservational study
The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)
Amniotic Fluid Embolism
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amniotic Fluid Embolism, run by Second Hospital of Shanxi 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 2 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: opening soon, as of the sponsor's last update on 28 May 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
STN (time frame: 24 hours). The study lists 2 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 28 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.