Amniotic Fluid EmbolismNCT06254092
Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section
A study testing tourniquet binding of cervical in people with Amniotic Fluid Embolism and Pulmonary Hypertension, run by First People's Hospital of Chenzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amniotic Fluid Embolism, Pulmonary Hypertension
- What is being tested?
- tourniquet binding of cervical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single pregnancy
- Be in good health, with no high blood pressure or heart disease during pregnancy
- Without placenta previa and placenta implantation
- No abdominal adhesions, suitable for operation
- Signed informed consent by the pregnant woman and her family
Who cannot join
- Serious coagulation abnormality
- Preoperative severe cardiac, cerebral, pulmonary, hepatic, renal and other important organs insufficiency and electrolyte abnormality combined with placenta praevia or placenta implantation
- Multiple pregnancies
- Previous history of abdominal surgery
- Intraoperative drug allergy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Amniotic Fluid Embolism, Pulmonary Hypertension
- Being tested
- tourniquet binding of cervical
- Keywords
- amniotic fluid entering the bloodstream, blood volume of amniotic fluid, Amniotic fluid embolism
- Medical subject headings
- Embolism, Amniotic Fluid, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tourniquet binding of cervicalProcedure or surgery
The procedure will be performed by surgeons with rich experience in clinical work
| Study group | Role | What they receive |
|---|---|---|
| tourniquet | Experimental | 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. Receives: Procedure: tourniquet binding of cervical |
What is being measured
The primary outcome is the main question the study is designed to answer.
sTn
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.
Measured: before the fetus is delivered,after the fetus is delivered,before the puerpera is sent back to the ward
Secondary outcomes (5)
HR MAP
Measurement of HR by patient monitor and MAP by placing an arterial puncture catheterization.
Measured: 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
SPO2,PaO2,PaCO2
the respiratory parameters in arterial blood gas
Measured: 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)
Thrombelastography (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.
Measured: before the fetus is delivered,before the puerpera is sent back to the ward
Adverse events
Irritability, chills, chest tightness and shortness of breath, transient drop in blood pressure, and nausea and vomiting
Measured: perioperatively
Hemorrhage
The using of tourniquets can reduce intraoperative hemorrhage. The postpartum hemorrhage reflects the coagulation function of patients.
Measured: before the puerpera is sent back to the ward, 2 hours after the puerpera back to ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start31 Jan 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic Fluid EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhiming zhang, First People's Hospital of Chenzhou
- Investigators
- Zhiming zhang, Principal investigator, Chenzhou NO. 1 people's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254092
- Sponsor's protocol ID
- 2023121
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section
- ClinicalTrials.gov ID
- NCT06254092
- Acronym / sponsor ID
- 2023121
- Conditions
- Amniotic Fluid Embolism, Pulmonary Hypertension
- Keywords
- amniotic fluid entering the bloodstream, blood volume of amniotic fluid, Amniotic fluid embolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tourniquet | Experimental | Procedure: tourniquet binding of cervicalThe 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Single pregnancy
- Be in good health, with no high blood pressure or heart disease during pregnancy
- Without placenta previa and placenta implantation
- No abdominal adhesions, suitable for operation
- Signed informed consent by the pregnant woman and her family
Key exclusion criteria (5 listed)
- Serious coagulation abnormality
- Preoperative severe cardiac, cerebral, pulmonary, hepatic, renal and other important organs insufficiency and electrolyte abnormality combined with placenta praevia or placenta implantation
- Multiple pregnancies
- Previous history of abdominal surgery
- Intraoperative drug allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tourniquet binding of cervicalThe procedure will be performed by surgeons with rich experience in clinical work | Procedure or surgery | tourniquet |
Primary outcome
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.
5 secondary outcomes
HR MAP
Time frame: 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
SPO2,PaO2,PaCO2
Time frame: 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)
Time frame: before the fetus is delivered,before the puerpera is sent back to the ward
Adverse events
Time frame: perioperatively
Hemorrhage
Time frame: before the puerpera is sent back to the ward, 2 hours after the puerpera back to ward
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Amniotic Fluid Embolism
RecruitingObservational study
The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)
Amniotic Fluid Embolism
Not yet recruitingObservational study
Analysis of Factors Associated With The Occurrence of Amniotic Fluid Entry in Patients Undergoing Caesarean Section
Amniotic Fluid Embolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiming zhang principal investigator
Chenzhou NO. 1 people's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tourniquet binding of cervical in people with Amniotic Fluid Embolism and Pulmonary Hypertension, run by First People's Hospital of Chenzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingying Zhou (+861861202387, zyy172250133@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sTn (time frame: before the fetus is delivered,after the fetus is delivered,before the puerpera is sent back to the ward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.