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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Hypertension; Amniotic Fluid Embolism
• Intervention / Treatment: Procedure: tourniquet binding of cervical

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingying Zhou; Phone Number: +861861202387; Email: zyy172250133@163.com
• Study Contact Backup: Name: Yao Chen; Phone Number: +8615115563778; Email: chenyao0810@163.com

Study Locations

• China
  • Hunan
    • Chenzhou, Hunan, China, 423000
      • Zhiming Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tourniquet; The investigators use tourniquets to bind the cervical for intervention groups to block venous return to the lower uterine segments to reduce the inflow of amniotic fluid into the uterus.	Procedure: tourniquet binding of cervical; The procedure will be performed by surgeons with rich experience in clinical work

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Adverse events	Irritability, chills, chest tightness and shortness of breath, transient drop in blood pressure, and nausea and vomiting	perioperatively
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

Collaborators and Investigators

• Sponsor: First People's Hospital of Chenzhou
• Investigators: Principal Investigator: Zhiming zhang, Chenzhou NO. 1 people's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: amniotic fluid entering the bloodstream; blood volume of amniotic fluid; Amniotic fluid embolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pregnancy Complications; Hypertension; Pregnancy Complications, Cardiovascular; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Embolism; Hypertension, Pulmonary; Embolism, Amniotic Fluid
• Other Study ID Numbers: 2023121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No