Personalized miscarriage risk score: does sharing risk affect anxiety in early pregnancy?
Official title: The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
Run by King's College Hospital NHS Trust · NCT07609602 · Data updated 2026-11-12
This study tests whether giving a personalized miscarriage risk score to people under 12 weeks with a single ongoing pregnancy affects their anxiety.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | Women only |
| Enrollment | 372 (estimated) |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | May 29, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07609602 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 16 or older with a single ongoing intrauterine pregnancy less than 12 weeks gestation who can understand English and consent to follow-up.
✕Probably not a fit
Patients who do not choose or benefit from receiving risk information or who experience anxiety worsened by risk disclosure may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this prospective randomized trial at a single center, participants with a confirmed single intrauterine pregnancy under 12 weeks are assigned to either receive a personalized miscarriage risk score or standard care without the score. The risk score is calculated from routinely collected clinical and ultrasound data, and communicated in a clear, non-directive format. Allocation is computer-generated with concealment, and follow-up includes pregnancy outcomes and participant-reported experiences to gauge acceptability and clarity. The trial aims to understand the psychological impact of sharing individualized risk information in the Early Pregnancy Unit setting.
Why it matters
Potential benefit: If successful, sharing the personalized risk score could help patients feel more informed and supported during early pregnancy care.
How similar studies have gone: Previous work in similar risk-communication approaches has shown mixed but informative psychological outcomes, making this evaluation important for clarity.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have capacity to understand the study and to provide signed and dated informed consent. * Willing to comply with all study procedures and be available for the duration of the study including consenting to follow up of the pregnancy outcome by letter, phone or email according to individual preference. * Age 16 years or over * Single live ongoing intrauterine pregnancy less than 12 weeks gestation Exclusion Criteria: Women with pregnancies of unknown location, ectopic pregnancies or early pregnancy prior to an embryo being seen or an embryo without a heartbeat. * Multiple pregnancies * Those undergoing assessment or treatment for a psychological condition by a psychiatrist * Those who do not speak English or require a translator * Women who have taken part in another clinical trial in the last 3 months.
Where it's running
-
King's College Hospital
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Jackie Ross, FRCOG — King's College Hospital NHS Trust
- Study coordinator: Eleanor Fleming, MBBS BSc MRCOG
- Email: eleanor.fleming@nhs.net
- Phone: +4420 3299 3168
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.