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

NCT ID: NCT06254092

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-08-01

Brief Summary

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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

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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.

Conditions

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Amniotic Fluid Embolism Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

tourniquet binding of cervical

Intervention Type PROCEDURE

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

Interventions

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tourniquet binding of cervical

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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First People's Hospital of Chenzhou

OTHER

Sponsor Role lead

Responsible Party

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zhiming zhang

chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiming zhang

Role: PRINCIPAL_INVESTIGATOR

Chenzhou NO. 1 people's Hospital

Locations

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Zhiming Zhang

Chenzhou, Hunan, China

Site Status

Countries

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China

Central Contacts

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Yingying Zhou

Role: CONTACT

+861861202387

Yao Chen

Role: CONTACT

+8615115563778

Other Identifiers

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2023121

Identifier Type: -

Identifier Source: org_study_id

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