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

NCT06930469 | Completed DMC

• 1 other identifier: 2022KT096
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• pre-hospital response time

  1 day

• intrahospital transport duration

  1 day

• emergency supply preparation time

  1 day

• complication rates

  28 days postpartum

• family psychological status measured

  28 days postpartum

Study Arms (2)

structured team model with shared decision-making

EXPERIMENTAL

Behavioral: structured team model with shared decision-making

conventional multidisciplinary resuscitation care

OTHER

Behavioral: conventional multidisciplinary resuscitation care

Interventions

structured team model with shared decision-making 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

structured team model with shared decision-making

conventional multidisciplinary resuscitation care 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

conventional multidisciplinary resuscitation care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meeting diagnostic criteria for critical obstetric conditions:
• Amniotic fluid embolism
• Postpartum hemorrhage
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ying Wang: lead

Study Sites (1)

Nantong First People's Hospital

Nantong, Jiangsu, 226000, China

Location

Related Publications (1)

• 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.

  PMID: 40922285 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 16, 2025
• Study Start: January 1, 2023
• Primary Completion: December 22, 2024
• Study Completion: February 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)