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

NCT06991985 | Not Yet Recruiting

• 1 other identifier: yuewei20250520
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Amniotic Fluid Embolism

Outcome Measures

Primary Outcomes (2)

• STN

  Serum STN levels

  24 hours

• C4

  Serum C4 levels

  24 hours

Study Arms (2)

Amniotic fluid into the blood group

Diagnostic Test: Enzyme-linked immunosorbent assay

the control group

Diagnostic Test: Enzyme-linked immunosorbent assay

Interventions

Enzyme-linked immunosorbent assay DIAGNOSTIC_TEST

Serum STN and C4 levels were detected

Amniotic fluid into the blood group; the control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the Second Hospital of Shanxi Medical University from May 2025 to November 2025

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (1)

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

MeSH Terms

Conditions

Embolism, Amniotic Fluid

Condition Hierarchy (Ancestors)

Pregnancy Complications, Cardiovascular; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiovascular Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: May 20, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)