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

NCT ID: NCT06930469

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-02-01

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

Conditions

Critical Illness; Pregnant Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

structured team model with shared decision-making

Group Type: EXPERIMENTAL

structured team model with shared decision-making

Intervention Type: BEHAVIORAL

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

conventional multidisciplinary resuscitation care

Group Type: OTHER

conventional multidisciplinary resuscitation care

Intervention Type: BEHAVIORAL

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

Interventions

structured 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

Intervention Type: BEHAVIORAL

conventional 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ying Wang

OTHER

Sponsor Role: lead

Responsible Party

Ying Wang

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nantong First People's Hospital

Nantong, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40922285 (View on PubMed)

Other Identifiers

2022KT096

Identifier Type: -

Identifier Source: org_study_id