Missed AbortionNCT07856940
GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion
A study testing GPT-Based Digital Assistant in people with Missed Abortion and Early Pregnancy Loss, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
We have developed a digital assistant based on GPT (Generative Pre-trained Transformer) technology, trained specifically to provide empathetic, medically accurate, and guideline-based responses in Hebrew, tailored to the clinical protocols used in our clinic. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Missed Abortion, Early Pregnancy Loss, Abortion in First Trimester
- What is being tested?
- GPT-Based Digital Assistant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2026to 30 Jan 2027
- Phase
- Interventional
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing medical abortion (up to 9 weeks gestation) or treatment for missed abortion (up to 12 weeks gestation)
- Hebrew-speaking
- Signed informed consent
Who cannot join
- No access to a smartphone or internet at home
- Non-Hebrew speakers
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
Edith Wolfson Medical Center
Holon, Central District
Liron Koren Arkin, MD, +972-545960296, lrnkoren@gmail.com
About this study
Official title: Feasibility and Usability of a GPT-Based Digital Assistant for Patients Undergoing Treatment for Induced Abortion or Missed Abortion: A Prospective Single-Arm Interventional Study
We have developed a digital assistant based on GPT (Generative Pre-trained Transformer) technology, trained specifically to provide empathetic, medically accurate, and guideline-based responses in Hebrew, tailored to the clinical protocols used in our clinic.
The goal of this interventional study is to learn about the feasibility, usability, and acceptability of a GPT-based digital assistant for patients undergoing medication abortion or treatment for missed abortion.
Read more
The study aims to assess use of the digital assistant, patient-reported usability, usefulness and satisfaction, perceived support, comprehension of treatment instructions, and decisions about contacting medical staff.
Participants already receiving standard care for medication abortion or missed abortion at the clinic will be offered access to the digital assistant immediately after enrollment. They may use the assistant freely at home throughout their treatment process and will complete baseline and follow-up surveys about their experience, emotional state, and any additional contacts with the clinic.
Read the detailed description
Medication abortion and treatment for missed abortion can be emotionally and physically demanding experiences. Patients may experience confusion, anxiety, and isolation during the home phase of treatment, and clinical instructions may be difficult to understand or follow during moments of stress or pain. Accessible, timely, and patient-centered information may help support patients throughout this process.
This prospective, single-arm, open-label, interventional feasibility study will assess the feasibility, usability, and acceptability of a GPT-based digital assistant designed to support patients undergoing induced abortion or treatment for missed abortion. The assistant is designed to provide empathetic, guideline-based information in Hebrew, tailored to the clinical protocols used in the clinic. It provides information in plain language and directs patients to the clinic or emergency care when appropriate.
Approximately 100 Hebrew-speaking patients undergoing induced abortion at up to 9 weeks of gestation or treatment for missed abortion at up to 12 weeks of gestation at Wolfson Medical Center will be enrolled during their initial clinic visit. After providing informed consent, participants will receive access to the digital assistant alongside standard clinical care. They may use the assistant as needed throughout the treatment process until the follow-up visit. There is no randomization or comparator group.
Baseline data will include demographic characteristics, previous abortion experience, and expectations regarding the digital assistant. Follow-up data will be collected through a study-specific questionnaire assessing assistant use, ease of use, usefulness, overall satisfaction, self-reported emotional state, perceived support, comprehension of treatment instructions, whether participants contacted medical staff and the type of contact, and whether they decided not to contact medical staff after receiving an answer from the assistant. Open-ended feedback will also be collected.
The study will evaluate feasibility and usage rates, patient satisfaction, perceived emotional support, and comprehension of treatment instructions. Participant feedback will be used to identify opportunities for improvement and explore potential integration into reproductive care.
The assistant is intended to supplement standard clinical information and support, rather than replace professional medical assessment or emergency services. Study data will be anonymized and stored securely in accordance with the approved protocol.
- Being tested
- GPT-Based Digital Assistant
- Keywords
- Medical abortion, Artificial Intelligence, GPT, Missed abortion, Early Pregnancy Loss, Digital Assistant, Chatbot, Feasibility Study, Patient Satisfaction
- Medical subject headings
- Abortion, Missed, Abortion, Spontaneous, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPT-Based Digital AssistantOther
a digital assistant based on GPT (Generative Pre-trained Transformer) technology, trained specifically to provide empathetic, medically accurate, and guideline-based responses in Hebrew, tailored to the clinical protocols used in our clinic. The assistant is designed to support patients throughout the medication abortion or missed abortion process, from the time of first medication until the follow-up visit. It offers culturally sensitive information in plain language, referring to the clinic or emergency care as needed.
| Study group | Role | What they receive |
|---|---|---|
| GPT-Based Digital Assistant Support | Experimental | Participants undergoing treatment for induced or missed abortion will receive access to a Hebrew-language GPT-based digital assistant upon enrollment, in addition to standard clinical care. Participants may use the assistant as needed until their follow-up visit. The assistant is designed to provide plain-language information about the treatment process, clarify clinical instructions, offer emotional support, and direct participants to the clinic or emergency services when appropriate. It supplements, rather than replaces, professional medical care. Receives: Other: GPT-Based Digital Assistant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and usage rates of the digital assistant
Feasibility will be assessed by the percentage of follow-up questionnaire respondents who report using the GPT-based digital assistant during the treatment process. Use will be assessed by a yes/no question in the study-specific, non-validated follow-up questionnaire. The number of respondents and the number of enrolled participants without follow-up data will also be reported.
Measured: From enrollment to follow-up at 2 weeks
Frequency of digital assistant use
Frequency of use will be assessed among participants who report using the GPT-based digital assistant, as assessed using the study-specific, non-validated follow-up questionnaire. Participants select one of four categories: once, 2-3 times, 4-5 times, or more than 5 times. The percentage of users in each category will be reported.
Measured: From enrollment through follow-up at 2 weeks
Patient satisfaction, usability, and perceived usefulness
Patient experience will be assessed among participants who used the GPT-based digital assistant, using three items in the study-specific, non-validated follow-up questionnaire: ease of use, perceived usefulness of the information, and overall satisfaction. Each item is rated from 1 (do not agree at all) to 5 (strongly agree). Higher scores indicate greater ease of use, usefulness, or satisfaction. Each item will be reported separately; no combined score will be calculated.
Measured: at 2 weeks after enrollment
Patient-reported decision not to contact medical staff after using the assistant
The percentage of assistant users who report an occasion when they considered contacting medical staff but felt that contact was unnecessary after receiving a response from the GPT-based digital assistant will be assessed using the study-specific, non-validated follow-up questionnaire. Response options are yes, no, and unsure. The distribution of responses will be reported.
Measured: at 2 weeks after enrollment
Perceived support and availability of answers
Perceived support will be assessed using two items in the study-specific, non-validated questionnaire: having sufficient support to cope with the process, and being able to obtain answers to questions when needed. Each item is rated from 1 (do not agree at all) to 5 (strongly agree), with higher scores indicating greater perceived support or availability of answers. Baseline and follow-up responses will be reported separately for each item.
Measured: At baseline before first use and at 2 weeks after enrollment.
Self-reported comprehension of treatment instructions
Self-reported comprehension will be assessed using three items in the study-specific, non-validated questionnaire addressing how and when to take medications, expected symptoms, and when to seek medical assistance. Each item is rated from 1 (do not agree at all) to 5 (strongly agree), with higher scores indicating greater perceived comprehension. Baseline and follow-up responses will be reported separately for each item.
Measured: At baseline before first use and at 2 weeks after enrollment.
Secondary outcomes (2)
Participant suggestions for improvement
Suggestions for improvement will be collected using the open-ended follow-up question asking participants what one thing they would change or improve in the GPT-based digital assistant. Responses will be summarized qualitatively and grouped into recurring themes.
Measured: at 2 weeks after enrollment
Insights into integration into reproductive care
An exploratory qualitative synthesis of participant suggestions for improvement will identify themes potentially relevant to integrating the digital assistant into routine reproductive care. This assessment will use responses to the open-ended follow-up question asking what participants would change or improve in the assistant and will not generate a numerical score.
Measured: at 2 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Missed AbortionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, open-label feasibility study. All enrolled participants undergoing treatment for induced or missed abortion will receive access to a Hebrew-language GPT-based digital assistant from enrollment until their follow-up visit, alongside standard clinical care. Participants may use the assistant voluntarily throughout this period. The study will assess feasibility, usage, usability, acceptability, and patient-reported experience. There is no randomization or comparator group.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Liron Koren Arkin, Wolfson Medical Center
- Investigators
- Liron Koren Arkin, Principal investigator, Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856940
- Sponsor's protocol ID
- WOMC-0019-26
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data. Study findings will be disseminated in aggregate form through scientific publications and presentations.
Publications
Wilson-Lowe RV, Purcell C, Lewis R, McDaid L. Seeking support for abortion online: a qualitative study of women's experiences. BMJ Sex Reprod Health. 2024 Jul 12;50(3):172-177. doi: 10.1136/bmjsrh-2023-202083.
PubMed 38336468Lewandowska M, Scott R, Meiksin R, Reiter J, Salaria N, Lohr PA, Cameron S, Palmer M, French RS, Wellings K; SACHA Study Team. How can patient experience of abortion care be improved? Evidence from the SACHA study. Womens Health (Lond). 2024 Jan-Dec;20:17455057241242675. doi: 10.1177/17455057241242675.
PubMed 38794997Upadhyay UD, Cockrill K, Freedman LR. Informing abortion counseling: an examination of evidence-based practices used in emotional care for other stigmatized and sensitive health issues. Patient Educ Couns. 2010 Dec;81(3):415-21. doi: 10.1016/j.pec.2010.08.026.
PubMed 20926226Koenig LR, Ko J, Valladares ES, Coeytaux FM, Wells E, Lyles CR, Upadhyay UD. Patient Acceptability of Telehealth Medication Abortion Care in the United States, 2021-2022: A Cohort Study. Am J Public Health. 2024 Feb;114(2):241-250. doi: 10.2105/AJPH.2023.307437. Epub 2024 Jan 18.
PubMed 38237103Shahrokhi SN, Salmani H, Ahmadi M. The Role of Electronic Health Tools in Unwanted Pregnancy Prevention, Abortion and Post-Abortion Follow-Up: A Systematic Review. Iran J Nurs Midwifery Res. 2023 Sep 8;28(5):487-503. doi: 10.4103/ijnmr.ijnmr_312_20. eCollection 2023 Sep-Oct.
PubMed 37869688Seymour JW, Goode BA, Guerrero P, Campos AM, Kyles K, Dreyfus-Pai P, Baum SE. Emotional, informational, and decision-making support needs among people seeking abortion in the US: perspectives from All-Options Talkline callers. Sex Reprod Health Matters. 2023 Dec;31(1):2248742. doi: 10.1080/26410397.2023.2248742. Epub 2023 Sep 20.
PubMed 37728428