Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-26 @ 11:26 AM
Study NCT ID:
NCT06254092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004619', 'term': 'Embolism, Amniotic Fluid'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D011249', 'term': 'Pregnancy Complications, Cardiovascular'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sTn', 'timeFrame': 'before the fetus is delivered,after the fetus is delivered,before the puerpera is sent back to the ward', 'description': "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."}], 'secondaryOutcomes': [{'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', 'description': 'Measurement of HR by patient monitor and MAP by placing an arterial puncture catheterization.'}, {'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', 'description': 'the respiratory parameters in arterial blood gas'}, {'measure': 'Thrombelastogram(TEG)', 'timeFrame': 'before the fetus is delivered,before the puerpera is sent back to the ward', 'description': '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.'}, {'measure': 'Adverse events', 'timeFrame': 'perioperatively', 'description': 'Irritability, chills, chest tightness and shortness of breath, transient drop in blood pressure, and nausea and vomiting'}, {'measure': 'Hemorrhage', 'timeFrame': 'before the puerpera is sent back to the ward, 2 hours after the puerpera back to ward', 'description': 'The using of tourniquets can reduce intraoperative hemorrhage. The postpartum hemorrhage reflects the coagulation function of patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['amniotic fluid entering the bloodstream', 'blood volume of amniotic fluid', 'Amniotic fluid embolism'], 'conditions': ['Amniotic Fluid Embolism', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Single pregnancy\n2. Be in good health, with no high blood pressure or heart disease during pregnancy\n3. Without placenta previa and placenta implantation\n4. No abdominal adhesions, suitable for operation\n5. Signed informed consent by the pregnant woman and her family\n\nExclusion criteria\n\n1. Serious coagulation abnormality\n2. Preoperative severe cardiac, cerebral, pulmonary, hepatic, renal and other important organs insufficiency and electrolyte abnormality combined with placenta praevia or placenta implantation\n3. Multiple pregnancies\n4. Previous history of abdominal surgery\n5. Intraoperative drug allergy'}, 'identificationModule': {'nctId': 'NCT06254092', 'briefTitle': 'Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Chenzhou"}, 'officialTitle': 'Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section', 'orgStudyIdInfo': {'id': '2023121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tourniquet', '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.', 'interventionNames': ['Procedure: tourniquet binding of cervical']}], 'interventions': [{'name': 'tourniquet binding of cervical', 'type': 'PROCEDURE', 'description': 'The procedure will be performed by surgeons with rich experience in clinical work', 'armGroupLabels': ['tourniquet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '423000', 'city': 'Chenzhou', 'state': 'Hunan', 'country': 'China', 'facility': 'Zhiming Zhang', 'geoPoint': {'lat': 25.8, 'lon': 113.03333}}], 'centralContacts': [{'name': 'Yingying Zhou', 'role': 'CONTACT', 'email': 'zyy172250133@163.com', 'phone': '+861861202387'}, {'name': 'Yao Chen', 'role': 'CONTACT', 'email': 'chenyao0810@163.com', 'phone': '+8615115563778'}], 'overallOfficials': [{'name': 'Zhiming zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Chenzhou NO. 1 people's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Chenzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief', 'investigatorFullName': 'zhiming zhang', 'investigatorAffiliation': "First People's Hospital of Chenzhou"}}}}