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

Ying Wang

Status: Completed

Conditions: Pregnant Women; Critical Illness

Treatments: Behavioral: conventional multidisciplinary resuscitation care; Behavioral: structured team model with shared decision-making

Study type: Interventional

Funder types: Other

Identifiers

NCT06930469

2022KT096

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

structured team model with shared decision-making

Experimental group

Treatment:

Behavioral: structured team model with shared decision-making

conventional multidisciplinary resuscitation care

Other group

Treatment:

Behavioral: conventional multidisciplinary resuscitation care