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

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

Study Overview

• Status: Completed
• Conditions: Critical Illness; Pregnant Women
• Intervention / Treatment: Behavioral: structured team model with shared decision-making; Behavioral: conventional multidisciplinary resuscitation care

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Nantong First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: structured team model with shared decision-making	Behavioral: 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
Other: conventional multidisciplinary resuscitation care	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal mortality in critically ill women	The mortality of critically ill parturients during hospitalization and the number of deaths/total number of parturients were recorded.	28 days postpartum
Neonatal survival rate	counting the survival of newborns within seven days after birth	Seven days after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pre-hospital response time	The pre-hospital emergency response time was recorded	1 day
intrahospital transport duration	The intra-hospital transport time was recorded	1 day
emergency supply preparation time	The preparation time of first aid items was recorded	1 day
complication rates	Complications such as fever, infection and pelvic hematoma were recorded during the rescue period.	28 days postpartum
family psychological status measured	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.	28 days postpartum
Satisfaction of family members	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.	28 days postpartum

Collaborators and Investigators

• Sponsor: Ying Wang

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 22, 2024
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2022KT096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We may have further research, and we may not consider releasing the research data until the results are announced

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No