An interventional study of LLM-Generated Medical Summaries in High-risk Pregnancy, Hospitalization and Patient Activation, sponsored by Sheba Medical Center. Not yet recruiting at 1 site in Israel. Open to female participants. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Health services research
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).
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.
409 studies on the registry are indexed under Patient Participation; 101 are open to participants now.
This study's planned enrollment of 200 is above the median of 128 across 322 interventional studies indexed under Patient Participation.
Browse Patient Participation studies →Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.
Compared within Patient Participation, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: LLM-Generated Medical Summaries
Participants receive standard care, which does not include LLM-generated medical summaries.
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.
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.
Time frame: 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.
Time frame: Throughout hospitalization, approximately 1-8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At delivery.
Umbilical Arterial Cord Blood pH
Umbilical arterial cord blood pH measured at delivery and collected from the medical record.
Time frame: At delivery.
Umbilical Venous Cord Blood pH
Umbilical venous cord blood pH measured at delivery and collected from the medical record.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From postpartum hospital discharge through 6 weeks postpartum.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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