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Analysis of Factors Associated With The Occurrence of Amniotic Fluid Entry in Patients Undergoing Caesarean Section

Analysis of Factors Associated With The Occurrence of Amniotic Fluid Entry in Patients Undergoing Caesarean Section

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06991985
Acronym
AOFAWTOOAFEIPU
Enrollment
120
Registered
2025-05-28
Start date
2025-05-20
Completion date
2025-12-31
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amniotic Fluid Embolism

Brief 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 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.

Interventions

DIAGNOSTIC_TESTEnzyme-linked immunosorbent assay

Serum STN and C4 levels were detected

Sponsors

Second Hospital of Shanxi Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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;

Exclusion criteria

* Suffer from diseases of the cardiorespiratory system; * Those with communication difficulties who were unable to complete the screening questionnaire;

Design outcomes

Primary

MeasureTime frameDescription
STN24 hoursSerum STN levels
C424 hoursSerum C4 levels

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026