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

F

First People's Hospital of Chenzhou

Status

Not yet enrolling

Conditions

Amniotic Fluid Embolism
Pulmonary Hypertension

Treatments

Procedure: tourniquet binding of cervical

Study type

Interventional

Funder types

Other

Identifiers

NCT06254092
2023121

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

tourniquet
Experimental group
Description:
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.
Treatment:
Procedure: tourniquet binding of cervical

Trial contacts and locations

1

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Central trial contact

Yao Chen; Yingying Zhou

Data sourced from clinicaltrials.gov

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