Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section

Pulmonary Hypertension Clinical Trial

Official title:

Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06254092
• Other study ID #: 2023121
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: First People's Hospital of Chenzhou
• Contact: Yingying Zhou
• Phone: +861861202387
• Email: zyy172250133[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to investigate whether the use of tourniquet after delivery of the fetus could reduce the amount of amniotic fluid entering the bloodstream and thus reduce the incidence of intraoperative adverse events.

Description:

Amniotic fluid embolism (AFE) is a rare complication specially to obstetrics.When amniotic fluid enters the maternal circulation , a sudden onset of a series of pathophysiologic changes such as pulmonary hypertension, hypoxemia, circulatory failure, disseminated intravascular coagulation, and multiorgan failure may occur. Routinely, the typical AFE triad is uneasy to discover, and nonspecific adverse reactions such as irritability, chills, chest tightness and shortness of breath, transient drop in blood pressure, and nausea and vomiting are often seen during delivery of the fetus and placenta. All of the above symptoms may suggest that the amniotic fluid has entered into the bloodstream. In clinical anesthesia, investigators observed that women with placenta praevia and placenta implantation were less likely to suffer these nonspecific symptoms after delivery of the fetus compared with women with normal pregnancies.The investigators speculated it might be related to the fact that obstetricians used tourniquets to reduce intraoperative hemorrhage in the former, blocking venous return to the lower uterine segments to reduce the inflow of amniotic fluid into the uterus. Therefore, this study was conducted to investigate whether the use of tourniquet after delivery of the fetus could reduce the amount of amniotic fluid entering the bloodstream and thus reduce the incidence of intraoperative adverse events.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion criteria

1. Single pregnancy

2. Be in good health, with no high blood pressure or heart disease during pregnancy

3. Without placenta previa and placenta implantation

4. No abdominal adhesions, suitable for operation

5. Signed informed consent by the pregnant woman and her family Exclusion criteria

1. Serious coagulation abnormality

2. Preoperative severe cardiac, cerebral, pulmonary, hepatic, renal and other important organs insufficiency and electrolyte abnormality combined with placenta praevia or placenta implantation

3. Multiple pregnancies

4. Previous history of abdominal surgery

5. Intraoperative drug allergy

Related Conditions & MeSH terms

• Amniotic Fluid Embolism
• Embolism
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Procedure:
• tourniquet binding of cervical
The procedure will be performed by surgeons with rich experience in clinical work

Locations

Country	Name	City	State
China	Zhiming Zhang	Chenzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Chenzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sTn	sTn refers to meconium and mucin extracted from amniotic fluid. The presence of sTn in the patient's serum is a diagnostic method that can directly prove that mucin derived from amniotic fluid has entered the maternal circulation.	before the fetus is delivered,after the fetus is delivered,before the puerpera is sent back to the ward
Secondary	HR MAP	Measurement of HR by patient monitor and MAP by placing an arterial puncture catheterization.	before the fetus is delivered,after the fetus is delivered,before the placenta is delivered,after the placenta is delivered,after releasing the tourniquet,before the puerpera is sent back to the ward
Secondary	SPO2,PaO2,PaCO2	the respiratory parameters in arterial blood gas	before the fetus is delivered,after the fetus is delivered,before the placenta is delivered,after the placenta is delivered,after releasing the tourniquet,before the puerpera is sent back to the ward
Secondary	Thrombelastogram(TEG)	Thrombelastography (TEG) is an indicator of the dynamic changes of blood coagulation. It can evaluate thrombelastography and compensate for the failure of routine examinations to reflect the fibrinolytic system and platelet function.	before the fetus is delivered,before the puerpera is sent back to the ward
Secondary	Adverse events	Irritability, chills, chest tightness and shortness of breath, transient drop in blood pressure, and nausea and vomiting	perioperatively
Secondary	Hemorrhage	The using of tourniquets can reduce intraoperative hemorrhage. The postpartum hemorrhage reflects the coagulation function of patients.	before the puerpera is sent back to the ward, 2 hours after the puerpera back to ward