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Clinical Trials/NCT06254092
NCT06254092
Not yet recruiting
Not Applicable

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

First People's Hospital of Chenzhou1 site in 1 country28 target enrollmentJanuary 31, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amniotic Fluid Embolism
Sponsor
First People's Hospital of Chenzhou
Enrollment
28
Locations
1
Primary Endpoint
sTn
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2024
End Date
August 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
First People's Hospital of Chenzhou
Responsible Party
Principal Investigator
Principal Investigator

zhiming zhang

chief

First People's Hospital of Chenzhou

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

sTn

Time Frame: before the fetus is delivered,after the fetus is delivered,before the puerpera is sent back to the ward

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.

Secondary Outcomes

  • HR MAP(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)
  • Adverse events(perioperatively)
  • Hemorrhage(before the puerpera is sent back to the ward, 2 hours after the puerpera back to ward)
  • SPO2,PaO2,PaCO2(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)(before the fetus is delivered,before the puerpera is sent back to the ward)

Study Sites (1)

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