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NCT Number: NCT06991985

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Enzyme-linked immunosorbent assay

Diagnostic Test

Serum STN and C4 levels were detected

Primary outcomes

  1. STN

    Time frame: 24 hours

    Serum STN levels

  2. C4

    Time frame: 24 hours

    Serum C4 levels

Sponsors and collaborators

Lead sponsor

Second Hospital of Shanxi Medical University

Other

Registry information

Acronym: AOFAWTOOAFEIPU

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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