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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06254092
Enrollment
28
Registered
2024-02-12
Start date
2024-01-31
Completion date
2024-08-01
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amniotic Fluid Embolism, Pulmonary Hypertension

Keywords

amniotic fluid entering the bloodstream, blood volume of amniotic fluid, Amniotic fluid embolism

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.

Interventions

PROCEDUREtourniquet binding of cervical

The procedure will be performed by surgeons with rich experience in clinical work

Sponsors

First People's Hospital of Chenzhou
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
sTnbefore the fetus is delivered,after the fetus is delivered,before the puerpera is sent back to the wardsTn 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

MeasureTime frameDescription
HR MAPbefore 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 wardMeasurement of HR by patient monitor and MAP by placing an arterial puncture catheterization.
SPO2,PaO2,PaCO2before 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 wardthe respiratory parameters in arterial blood gas
Thrombelastogram(TEG)before the fetus is delivered,before the puerpera is sent back to the wardThrombelastography (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.
Adverse eventsperioperativelyIrritability, chills, chest tightness and shortness of breath, transient drop in blood pressure, and nausea and vomiting
Hemorrhagebefore the puerpera is sent back to the ward, 2 hours after the puerpera back to wardThe using of tourniquets can reduce intraoperative hemorrhage. The postpartum hemorrhage reflects the coagulation function of patients.

Countries

China

Contacts

Primary ContactYingying Zhou
zyy172250133@163.com+861861202387
Backup ContactYao Chen
chenyao0810@163.com+8615115563778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026