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Shared Decision-Making Structured Team Model for Critical Maternal Care in OB-GYN ICU

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06930469
Enrollment
100
Registered
2025-04-16
Start date
2023-01-01
Completion date
2025-02-01
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Pregnant Women

Brief summary

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

Interventions

BEHAVIORALstructured team model with shared decision-making

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

BEHAVIORALconventional multidisciplinary resuscitation care

The observation group implemented a structured team model based on a shared decision-making model, which operated as follows: (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

Sponsors

Ying Wang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Meeting diagnostic criteria for critical obstetric conditions: 1. Amniotic fluid embolism 2. Postpartum hemorrhage 3. Emergency cesarean section was performed, etc * Age ≥18 years * Gestational age \>20 weeks * Patient's family/legal representative capable of normal communication and providing signed informed consent

Exclusion criteria

* Pre-existing primary hematologic disorders: * Fetal congenital anomalies confirmed by prenatal imaging * Active malignant tumors (except carcinoma in situ) * Severe organ dysfunction: * Altered mental status (GCS ≤12) or documented psychiatric disorders

Design outcomes

Primary

MeasureTime frameDescription
Maternal mortality in critically ill women28 days postpartumThe mortality of critically ill parturients during hospitalization and the number of deaths/total number of parturients were recorded.
Neonatal survival rateSeven days after birthcounting the survival of newborns within seven days after birth

Secondary

MeasureTime frameDescription
emergency supply preparation time1 dayThe preparation time of first aid items was recorded
complication rates28 days postpartumComplications such as fever, infection and pelvic hematoma were recorded during the rescue period.
pre-hospital response time1 dayThe pre-hospital emergency response time was recorded
Satisfaction of family members28 days postpartumThe 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.
family psychological status measured28 days postpartumThe 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.
intrahospital transport duration1 dayThe intra-hospital transport time was recorded

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026