Clinical trial NCT06254092: Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section
Official title: Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Amniotic Fluid Embolism
Pulmonary Hypertension
Keywords: amniotic fluid entering the bloodstream
blood volume of amniotic fluid
Amniotic fluid embolism
Lead sponsor: First People's Hospital of Chenzhou
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: sTn
timeFrame: before the fetus is delivered,after the fetus is delivered,before the puerpera is sent back to the ward
Secondary outcomes:
measure: HR MAP
timeFrame: 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
measure: SPO2,PaO2,PaCO2
timeFrame: 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
measure: Thrombelastogram(TEG)
timeFrame: before the fetus is delivered,before the puerpera is sent back to the ward
measure: Adverse events
timeFrame: perioperatively
measure: Hemorrhage
timeFrame: before the puerpera is sent back to the ward, 2 hours after the puerpera back to ward
Other outcomes:
Locations:
city: Chenzhou
country: China
facility: Zhiming Zhang
state: Hunan
Study officials:
affiliation: Chenzhou NO. 1 people's Hospital
name: Zhiming zhang
role: PRINCIPAL_INVESTIGATOR
References: