Critical IllnessNCT06930469
Shared Decision-Making Structured Team Model for Critical Maternal Care in OB-GYN ICU
A study testing structured team model with shared decision-making and conventional multidisciplinary resuscitation care in people with Critical Illness and Pregnant Women, run by Ying Wang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Critical Illness, Pregnant Women
- What is being tested?
- structured team model with shared decision-making and conventional multidisciplinary resuscitation care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Critical Illness, Pregnant Women
- Being tested
- structured team model with shared decision-making, conventional multidisciplinary resuscitation care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structured team model with shared decision-makingBehavioural
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 careBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| structured team model with shared decision-making | Experimental | Not described Receives: Behavioral: structured team model with shared decision-making |
| conventional multidisciplinary resuscitation care | Other | Not described Receives: Behavioral: conventional multidisciplinary resuscitation care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days postpartum
Neonatal survival rate
counting the survival of newborns within seven days after birth
Measured: Seven days after birth
Secondary outcomes (6)
pre-hospital response time
The pre-hospital emergency response time was recorded
Measured: 1 day
intrahospital transport duration
The intra-hospital transport time was recorded
Measured: 1 day
emergency supply preparation time
The preparation time of first aid items was recorded
Measured: 1 day
complication rates
Complications such as fever, infection and pelvic hematoma were recorded during the rescue period.
Measured: 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.
Measured: 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.
Measured: 28 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Jan 2023
- Primary completion22 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ying Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ying Wang, Nantong First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930469
- Sponsor's protocol ID
- 2022KT096
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We may have further research, and we may not consider releasing the research data until the results are announced
Publications
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.
PubMed 40922285
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06930469
- Acronym / sponsor ID
- 2022KT096
- Conditions
- Critical Illness, Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ying WangUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meeting diagnostic criteria for critical obstetric conditions:
- Age ≥18 years
- Gestational age >20 weeks
- Patient's family/legal representative capable of normal communication and providing signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| structured team model with shared decision-makingStructured 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 | Behavioural | structured team model with shared decision-making |
| conventional multidisciplinary resuscitation careThe 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 | Behavioural | conventional multidisciplinary resuscitation care |
Primary outcome
Maternal mortality in critically ill women
Time frame: 28 days postpartum
The mortality of critically ill parturients during hospitalization and the number of deaths/total number of parturients were recorded.
Neonatal survival rate
Time frame: Seven days after birth
counting the survival of newborns within seven days after birth
6 secondary outcomes
pre-hospital response time
Time frame: 1 day
intrahospital transport duration
Time frame: 1 day
emergency supply preparation time
Time frame: 1 day
complication rates
Time frame: 28 days postpartum
family psychological status measured
Time frame: 28 days postpartum
Satisfaction of family members
Time frame: 28 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 40922285Lu 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.
- Individual participant dataSharing planned: No. We may have further research, and we may not consider releasing the research data until the results are announced
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured team model with shared decision-making and conventional multidisciplinary resuscitation care in people with Critical Illness and Pregnant Women, run by Ying Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal mortality in critically ill women (time frame: 28 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06930469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.