High-risk PregnancyNCT07823517
LLM-Generated Medical Summaries During Hospitalization to Improve Patient Activation in High-Risk Pregnancies
A study testing LLM-Generated Medical Summaries in people with High-risk Pregnancy and Hospitalization, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The goal of this clinical trial is to learn if AI-generated medical summaries help hospitalized pregnant participants better understand and actively participate in their own care. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- High-risk Pregnancy, Hospitalization, Patient Activation
- What is being tested?
- LLM-Generated Medical Summaries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2026to 23 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted to the antepartum high-risk department at Sheba Medical Center
- Able to provide written informed consent
- Able to read and understand Hebrew, English, or Arabic
Who cannot join
- Expected hospitalization of less than 3 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Sheba Medical Center
Ramat Gan, 5262000
Avihu Krieger, MD, 0547421909, avihuey@gmail.com
avihuey@gmail.com
About this study
Official title: The Effect of Large Language Model-Generated Medical Summaries on Patient Activation During Antepartum Hospitalization: A Randomized Controlled Trial
The goal of this clinical trial is to learn if AI-generated medical summaries help hospitalized pregnant participants better understand and actively participate in their own care. The main questions it aims to answer are:
Do AI-generated summaries increase participant activation (knowledge, skills, and confidence in managing their health)? How accurate are the AI-generated summaries, as assessed by physicians? Do AI-generated summaries affect depressive symptoms during hospitalization?
Read more
Researchers will compare participants who receive periodic AI-generated summaries of their medical care with participants who receive standard care to determine whether the summaries improve patient activation during hospitalization.
Participants will:
Be randomly assigned to receive AI-generated medical summaries or standard care.
Complete the Patient Activation Measure (PAM-13) at baseline before the intervention and again after the intervention.
Complete the Edinburgh Postnatal Depression Scale (EPDS) at baseline and again after the intervention.
Receive up to 3 summaries during their hospitalization (intervention group only).
Read the detailed description
Hospitalized pregnant participants in high-risk antepartum units may face complex medical conditions and treatment plans and may have difficulty understanding all of the medical information provided during hospitalization. This may reduce their ability to actively participate in their own care.
In this study, participants will be randomly assigned in a 1:1 ratio to one of two groups. Randomization will be stratified by gestational age at enrollment (<32+0 weeks vs. ≥32+0 weeks) using permuted blocks with randomly varying block sizes.
Participants in the intervention group will receive periodic medical summaries generated by a large language model (LLM) using a secure, privacy-protected AI environment at Sheba Medical Center. Each summary will be reviewed by a physician for medical accuracy before being provided to the participant. If a summary is considered inadequate, the physician may correct it before providing it to the participant or reject it, in which case it will not be provided.
The first summary will be generated on days 3-5 of hospitalization. Updated summaries will subsequently be generated every 3-5 days, with a maximum of 3 summaries per participant during hospitalization.
Participants in the control group will receive standard care without LLM-generated medical summaries.
The researchers will investigate:
Whether LLM-generated summaries improve patient activation, defined as the knowledge, skills, and confidence participants have in managing their own health, as measured by the Patient Activation Measure (PAM-13).
Whether LLM-generated summaries affect depressive symptoms during hospitalization, as measured by the Edinburgh Postnatal Depression Scale (EPDS).
The accuracy of LLM-generated medical summaries as assessed by physicians, including whether summaries require modification or rejection before being provided to participants.
Obstetric, neonatal, and postpartum clinical outcomes collected from the medical record.
- Being tested
- LLM-Generated Medical Summaries
- Keywords
- Large Language Model, Artificial Intelligence, Patient Activation, High-Risk Pregnancy, Antepartum Hospitalization, Medical Summaries, Postnatal Depression, PAM-13, EPDS
- Medical subject headings
- Patient Participation, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM-Generated Medical SummariesOther
Participants receive patient-facing written medical summaries generated by a large language model (LLM) using a secure, privacy-protected AI environment at Sheba Medical Center. The intervention is informational and does not involve administration of a drug, use of a medical device, or performance of a medical procedure. Each summary is reviewed by a physician for medical accuracy before being provided to the participant. If a summary is deemed inadequate, it may be corrected by the reviewing physician before delivery or rejected and not provided. The first summary is generated on days 3-5 of hospitalization, with updated summaries every 3-5 days and a maximum of 3 summaries per participant.
| Study group | Role | What they receive |
|---|---|---|
| LLM-Generated Medical Summaries | Experimental | Participants receive periodic patient-facing written medical summaries generated by a large language model (LLM) using a secure, privacy-protected AI environment at Sheba Medical Center. This is an informational intervention and does not involve a drug, medical device, or medical procedure. Each summary is reviewed by a physician for medical accuracy before delivery. Summaries are generated every 3-5 days, beginning on days 3-5 of hospitalization, with a maximum of 3 summaries per participant. Receives: Other: LLM-Generated Medical Summaries |
| Standard Care | No intervention | Participants receive standard care, which does not include LLM-generated medical summaries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Activation Measure Score
Change in Patient Activation Measure (PAM-13) score from baseline (pre-intervention) to post-intervention, compared between the intervention and control groups. The PAM-13 is a 13-item instrument assessing patient knowledge, skills, and confidence in managing their own health. Scores range from 0 to 100, with higher scores indicating greater patient activation.
Measured: From baseline (pre-intervention) to post-intervention during hospitalization, approximately 1-8 weeks.
Number of LLM-Generated Medical Summaries Requiring Physician Modification or Rejection
Number of LLM-generated medical summaries that require physician modification or are rejected following physician review and prior to delivery to the participant.
Measured: Throughout hospitalization, approximately 1-8 weeks
Secondary outcomes (18)
Change in Edinburgh Postnatal Depression Scale Score
Change in EPDS score from baseline (admission) to end of hospitalization (prior to discharge), compared between the intervention and control groups. The EPDS is a 10-item self-report instrument with scores ranging from 0 to 30. A score of 10 or above indicates clinically significant depressive symptoms.
Measured: From admission to discharge, approximately 1-8 weeks
Gestational Age at Delivery
Gestational age at delivery, measured in weeks and days, collected from the medical record and compared between the intervention and control groups.
Measured: At delivery, up to approximately 6 months after enrollment.
Mode of Delivery
Mode of delivery, categorized as spontaneous vaginal delivery, operative vaginal delivery, or cesarean delivery, collected from the medical record and compared between the intervention and control groups.
Measured: At delivery, up to approximately 6 months after enrollment.
Indication for Cesarean Delivery
Indication for cesarean delivery among participants undergoing cesarean delivery, collected from the medical record.
Measured: At delivery, up to approximately 6 months after enrollment.
Maternal Fever or Chorioamnionitis
Proportion of participants diagnosed with maternal fever or chorioamnionitis during pregnancy or delivery, collected from the medical record and compared between the intervention and control groups.
Measured: From enrollment through delivery, up to approximately 6 months.
Length of Antepartum Hospitalization
Duration of antepartum hospitalization in days, collected from the medical record and compared between the intervention and control groups.
Measured: From admission to discharge from the antepartum hospitalization, approximately 1-8 weeks.
Antepartum Readmission or Emergency Department Visit
Proportion of participants with hospital readmission or an emergency department visit following discharge from the index antepartum hospitalization and prior to delivery.
Measured: From discharge from the index hospitalization through delivery, up to approximately 6 months after enrollment.
Birth Weight
Neonatal birth weight in grams, collected from the medical record and compared between the intervention and control groups.
Measured: At delivery, up to approximately 6 months after enrollment.
Apgar Score at 1 Minute
Apgar score at 1 minute after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition.
Measured: At delivery.
Apgar Score at 5 Minutes
Apgar score at 5 minutes after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition.
Measured: At delivery.
Umbilical Arterial Cord Blood pH
Umbilical arterial cord blood pH measured at delivery and collected from the medical record.
Measured: At delivery.
Umbilical Venous Cord Blood pH
Umbilical venous cord blood pH measured at delivery and collected from the medical record.
Measured: At delivery.
Umbilical Arterial and Venous Cord Blood Base Excess
Umbilical arterial and Venous cord blood base excess measured at delivery and collected from the medical record.
Measured: At delivery.
Neonatal Intensive Care Unit Admission
Proportion of newborns admitted to the neonatal intensive care unit (NICU), collected from the medical record and compared between the intervention and control groups.
Measured: From birth through neonatal hospital discharge, assessed up to 6 months after birth.
Postpartum Endometritis
Proportion of participants diagnosed with postpartum endometritis, collected from the medical record and compared between the intervention and control groups.
Measured: From delivery through 6 weeks postpartum.
Postpartum Hemorrhage
Proportion of participants experiencing postpartum hemorrhage, defined as estimated blood loss greater than 1000 mL, collected from the medical record and compared between the intervention and control groups.
Measured: From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
Length of Postpartum Hospitalization
Duration of postpartum hospitalization in days, collected from the medical record and compared between the intervention and control groups.
Measured: From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
Postpartum Readmission or Emergency Department Visit
Proportion of participants with hospital readmission or an emergency department visit during the postpartum period.
Measured: From postpartum hospital discharge through 6 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion23 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk PregnancyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Avihu Krieger, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823517
- Sponsor's protocol ID
- SMC-25-2019
- Status last verified
- Sep 2026
- First submitted
- 15 May 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is planned as a single-center trial, and at this stage, there are no plans or agreements in place for sharing individual participant data (IPD). Future considerations for data-sharing agreements may be evaluated based on future research collaborations and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Large Language Model-Generated Medical Summaries on Patient Activation During Antepartum Hospitalization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07823517
- Acronym / sponsor ID
- SMC-25-2019
- Keywords
- Large Language Model, Artificial Intelligence, Patient Activation, High-Risk Pregnancy, Antepartum Hospitalization, Medical Summaries, Postnatal Depression, PAM-13
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 23 Jul 2028 (estimated)
- First posted
- 16 Sep 2026 (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.
The goal of this clinical trial is to learn if AI-generated medical summaries help hospitalized pregnant participants better understand and actively participate in their own care. The main questions it aims to answer are:
Do AI-generated summaries increase participant activation (knowledge, skills, and confidence in managing their health)? How accurate are the AI-generated summaries, as assessed by physicians? Do AI-generated summaries affect depressive symptoms during hospitalization?
Researchers will compare participants who receive periodic AI-generated summaries of their medical care with participants who receive standard care to determine whether the summaries improve patient activation during hospitalization.
Participants will:
Be randomly assigned to receive AI-generated medical summaries or standard care.
Complete the Patient Activation Measure (PAM-13) at baseline before the intervention and again after the intervention.
Complete the Edinburgh Postnatal Depression Scale (EPDS) at baseline and again after the intervention.
Receive up to 3 summaries during their hospitalization (intervention group only).
Detailed description
Hospitalized pregnant participants in high-risk antepartum units may face complex medical conditions and treatment plans and may have difficulty understanding all of the medical information provided during hospitalization. This may reduce their ability to actively participate in their own care.
In this study, participants will be randomly assigned in a 1:1 ratio to one of two groups. Randomization will be stratified by gestational age at enrollment (<32+0 weeks vs. ≥32+0 weeks) using permuted blocks with randomly varying block sizes.
Participants in the intervention group will receive periodic medical summaries generated by a large language model (LLM) using a secure, privacy-protected AI environment at Sheba Medical Center. Each summary will be reviewed by a physician for medical accuracy before being provided to the participant. If a summary is considered inadequate, the physician may correct it before providing it to the participant or reject it, in which case it will not be provided.
The first summary will be generated on days 3-5 of hospitalization. Updated summaries will subsequently be generated every 3-5 days, with a maximum of 3 summaries per participant during hospitalization.
Participants in the control group will receive standard care without LLM-generated medical summaries.
The researchers will investigate:
Whether LLM-generated summaries improve patient activation, defined as the knowledge, skills, and confidence participants have in managing their own health, as measured by the Patient Activation Measure (PAM-13).
Whether LLM-generated summaries affect depressive symptoms during hospitalization, as measured by the Edinburgh Postnatal Depression Scale (EPDS).
The accuracy of LLM-generated medical summaries as assessed by physicians, including whether summaries require modification or rejection before being provided to participants.
Obstetric, neonatal, and postpartum clinical outcomes collected from the medical record.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLM-Generated Medical Summaries | Experimental | Other: LLM-Generated Medical SummariesParticipants receive periodic patient-facing written medical summaries generated by a large language model (LLM) using a secure, privacy-protected AI environment at Sheba Medical Center. This is an informational intervention and does not involve a drug, medical device, or medical procedure. Each summary is reviewed by a physician for medical accuracy before delivery. Summaries are generated every 3-5 days, beginning on days 3-5 of hospitalization, with a maximum of 3 summaries per participant. |
| Standard Care | No intervention | –Participants receive standard care, which does not include LLM-generated medical summaries. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the antepartum high-risk department at Sheba Medical Center
- Able to provide written informed consent
- Able to read and understand Hebrew, English, or Arabic
Key exclusion criteria (1 listed)
- Expected hospitalization of less than 3 days
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 |
|---|---|---|
| LLM-Generated Medical SummariesParticipants receive patient-facing written medical summaries generated by a large language model (LLM) using a secure, privacy-protected AI environment at Sheba Medical Center. The intervention is informational and does not involve administration of a drug, use of a medical device, or performance of a medical procedure. Each summary is reviewed by a physician for medical accuracy before being provided to the participant. If a summary is deemed inadequate, it may be corrected by the reviewing physician before delivery or rejected and not provided. The first summary is generated on days 3-5 of hospitalization, with updated summaries every 3-5 days and a maximum of 3 summaries per participant. | Other | LLM-Generated Medical Summaries |
Primary outcome
Change in Patient Activation Measure Score
Time frame: From baseline (pre-intervention) to post-intervention during hospitalization, approximately 1-8 weeks.
Change in Patient Activation Measure (PAM-13) score from baseline (pre-intervention) to post-intervention, compared between the intervention and control groups. The PAM-13 is a 13-item instrument assessing patient knowledge, skills, and confidence in managing their own health. Scores range from 0 to 100, with higher scores indicating greater patient activation.
Number of LLM-Generated Medical Summaries Requiring Physician Modification or Rejection
Time frame: Throughout hospitalization, approximately 1-8 weeks
Number of LLM-generated medical summaries that require physician modification or are rejected following physician review and prior to delivery to the participant.
18 secondary outcomes
Change in Edinburgh Postnatal Depression Scale Score
Time frame: From admission to discharge, approximately 1-8 weeks
Gestational Age at Delivery
Time frame: At delivery, up to approximately 6 months after enrollment.
Mode of Delivery
Time frame: At delivery, up to approximately 6 months after enrollment.
Indication for Cesarean Delivery
Time frame: At delivery, up to approximately 6 months after enrollment.
Maternal Fever or Chorioamnionitis
Time frame: From enrollment through delivery, up to approximately 6 months.
Length of Antepartum Hospitalization
Time frame: From admission to discharge from the antepartum hospitalization, approximately 1-8 weeks.
Antepartum Readmission or Emergency Department Visit
Time frame: From discharge from the index hospitalization through delivery, up to approximately 6 months after enrollment.
Birth Weight
Time frame: At delivery, up to approximately 6 months after enrollment.
Apgar Score at 1 Minute
Time frame: At delivery.
Apgar Score at 5 Minutes
Time frame: At delivery.
Umbilical Arterial Cord Blood pH
Time frame: At delivery.
Umbilical Venous Cord Blood pH
Time frame: At delivery.
Umbilical Arterial and Venous Cord Blood Base Excess
Time frame: At delivery.
Neonatal Intensive Care Unit Admission
Time frame: From birth through neonatal hospital discharge, assessed up to 6 months after birth.
Postpartum Endometritis
Time frame: From delivery through 6 weeks postpartum.
Postpartum Hemorrhage
Time frame: From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
Length of Postpartum Hospitalization
Time frame: From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
Postpartum Readmission or Emergency Department Visit
Time frame: From postpartum hospital discharge through 6 weeks postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. This study is planned as a single-center trial, and at this stage, there are no plans or agreements in place for sharing individual participant data (IPD). Future considerations for data-sharing agreements may be evaluated based on future research collaborations and institutional policies.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLM-Generated Medical Summaries in people with High-risk Pregnancy and Hospitalization, run by Sheba Medical Center at 1 site in Israel.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 16 Sep 2026. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avihu Krieger, MD (+972547421909, avihuey@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Activation Measure Score (time frame: From baseline (pre-intervention) to post-intervention during hospitalization, approximately 1-8 weeks.). 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?
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 Sep 2026.