Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-28 @ 8:10 PM
Study NCT ID:
NCT06930469
Status:
COMPLETED
Last Update Posted:
2025-04-16
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Decision-Making Structured Team Model for Critical Maternal Care in OB-GYN ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal mortality in critically ill women', 'timeFrame': '28 days postpartum', 'description': 'The mortality of critically ill parturients during hospitalization and the number of deaths/total number of parturients were recorded.'}, {'measure': 'Neonatal survival rate', 'timeFrame': 'Seven days after birth', 'description': 'counting the survival of newborns within seven days after birth'}], 'secondaryOutcomes': [{'measure': 'pre-hospital response time', 'timeFrame': '1 day', 'description': 'The pre-hospital emergency response time was recorded'}, {'measure': 'intrahospital transport duration', 'timeFrame': '1 day', 'description': 'The intra-hospital transport time was recorded'}, {'measure': 'emergency supply preparation time', 'timeFrame': '1 day', 'description': 'The preparation time of first aid items was recorded'}, {'measure': 'complication rates', 'timeFrame': '28 days postpartum', 'description': 'Complications such as fever, infection and pelvic hematoma were recorded during the rescue period.'}, {'measure': 'family psychological status measured', 'timeFrame': '28 days postpartum', 'description': 'The Hospital Anxiety and Depression Scale (HADS) was used for evaluation, which consists of two subscales, including anxiety and depression, each with 7 items. The scale is scored on a 4-point scale, and the total score is 0-21. The higher the score, the more serious the anxiety or depression.'}, {'measure': 'Satisfaction of family members', 'timeFrame': '28 days postpartum', 'description': 'The Chinese version of critical care family satisfaction survey (CCFSS) was used for evaluation. The scale consisted of 5 dimensions and 20 items, including disease assurance, access to information, acceptance, support, and comfort. There were 4, 5, 3, 6, and 2 items in sequence, and a 5-point scale was used. The total score ranged from 20 to 100, with higher scores indicating higher family satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Pregnant Women']}, 'referencesModule': {'references': [{'pmid': '40922285', 'type': 'DERIVED', 'citation': 'Lu Y, Cai H, Chen L, Ni X, Ji J, Zhou Y, Liu Y, Jiang Y, Wang Y. Application of structured team model based on shared decision model in obstetrics and gynecology joint intensive care unit (ICU) rescue of critical care pregnant women: A randomized controlled trial. Medicine (Baltimore). 2025 Sep 5;104(36):e44430. doi: 10.1097/MD.0000000000044430.'}]}, 'descriptionModule': {'briefSummary': "A randomized controlled trial was conducted with 100 critically ill pregnant women admitted to our hospital's obstetrics ICU between January 2023 and December 2024. Participants were allocated via random number table to either the control group receiving conventional multidisciplinary resuscitation care (n=50) or the observation group receiving the structured team model with shared decision-making (n=50). Comparative outcomes included resuscitation efficiency indicators (pre-hospital response time, intrahospital transport duration, emergency supply preparation time), complication rates, family psychological status measured by Hospital Anxiety and Depression Scale (HADS), and family satisfaction assessments"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meeting diagnostic criteria for critical obstetric conditions:\n\n 1. Amniotic fluid embolism\n 2. Postpartum hemorrhage\n 3. Emergency cesarean section was performed, etc\n* Age ≥18 years\n* Gestational age \\>20 weeks\n* Patient's family/legal representative capable of normal communication and providing signed informed consent\n\nExclusion Criteria:\n\n* Pre-existing primary hematologic disorders:\n* Fetal congenital anomalies confirmed by prenatal imaging\n* Active malignant tumors (except carcinoma in situ)\n* Severe organ dysfunction:\n* Altered mental status (GCS ≤12) or documented psychiatric disorders"}, 'identificationModule': {'nctId': 'NCT06930469', 'briefTitle': 'Shared Decision-Making Structured Team Model for Critical Maternal Care in OB-GYN ICU', 'organization': {'class': 'OTHER', 'fullName': "Nantong First People's Hospital"}, 'officialTitle': 'Application of Structured Team Model Based on Shared Decision Model in Obstetrics and Gynecology Joint Intensive Care Unit (ICU) Rescue of Critical Care Pregnant Women', 'orgStudyIdInfo': {'id': '2022KT096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'structured team model with shared decision-making', 'interventionNames': ['Behavioral: structured team model with shared decision-making']}, {'type': 'OTHER', 'label': 'conventional multidisciplinary resuscitation care', 'interventionNames': ['Behavioral: conventional multidisciplinary resuscitation care']}], 'interventions': [{'name': 'structured team model with shared decision-making', 'type': 'BEHAVIORAL', 'description': 'Structured team model based on shared decision-making model: ① Maternal Critical Care Review: Pre-hospital (prenatal checkup): Obstetricians and nurses conduct regular prenatal checkups for mothers, identify high-risk mothers, and set up high-risk maternal health records. Referral: Critically ill pregnant women establish a green channel for timely referral to the obstetrics department or ICU, and contact the relevant personnel of the structured management team. Assessment: The multidisciplinary team conducts a comprehensive assessment of the extent of the maternal condition, vital signs, and laboratory test results. Identification: Identify the main causes of critical maternal illness and potential risks, such as hemorrhage, infection, and organ failure. Rescue plan: according to the assessment results, formulate a personalized rescue plan and clarify the responsibilities and tasks of each department. Monitoring: real-time monitoring of maternal vital signs and changes in condition, a', 'armGroupLabels': ['structured team model with shared decision-making']}, {'name': 'conventional multidisciplinary resuscitation care', 'type': 'BEHAVIORAL', 'description': "The observation group implemented a structured team model based on a shared decision-making model, which operated as follows:\n\n(1) Constructing a structured management team: multidisciplinary medical and nursing staff, including obstetricians, ICU doctors, obstetric nurses, ICU nurses, head nurses, anesthesiologists, ultrasonographers, and family members of the patient's main companions, are divided into small teams according to their functions, and each small team has a team leader who is responsible for the coordination of the overall situation and the rapid coordination of information. Obstetricians and ICU doctors are responsible for life support, obstetric evaluation, condition monitoring and development of resuscitation plan for critically ill mothers. Anesthesiologists are responsible for anesthesia management, pain control and intraoperative resuscitation support. The nurse manager coordinates the nursing team to ensure the standardization of rescue care. Obstetrician and ICU nu", 'armGroupLabels': ['conventional multidisciplinary resuscitation care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '226000', 'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': "Nantong First People's Hospital", 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We may have further research, and we may not consider releasing the research data until the results are announced'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ying Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Ying Wang', 'investigatorAffiliation': "Nantong First People's Hospital"}}}}