Early Pregnancy BleedingPEMPSNCT07609602
The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
A study testing Miscarriage prediction score and Will not receive miscarriage prediction score in people with Early Pregnancy Bleeding, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Patients Under 12 Weeks Pregnant With a Single Ongoing Pregnancy Attending the EPU Will be Randomly Assigned to Receive Their Personalised Miscarriage Risk Score or Not. The Study Explores Whether Sharing This Score Affects Anxiety and Whether Patients Find the Information Helpful and Acceptable. (PEMPS) Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Early Pregnancy Bleeding
- What is being tested?
- Miscarriage prediction score and Will not receive miscarriage prediction score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 May 2026to 1 Jul 2027
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jackie Ross contact
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE5 9RS
Jackie Ross, MD, +442032999000 ext. 31703, kch-tr.epagsu@nhs.net
About this study
Patients Under 12 Weeks Pregnant With a Single Ongoing Pregnancy Attending the EPU Will be Randomly Assigned to Receive Their Personalised Miscarriage Risk Score or Not. The Study Explores Whether Sharing This Score Affects Anxiety and Whether Patients Find the Information Helpful and Acceptable. (PEMPS)
Read the detailed description
The PEMPS study is a prospective, randomised controlled investigation designed to evaluate the psychological impact of providing individualised miscarriage risk estimates to patients in early pregnancy. The study population comprises individuals attending an Early Pregnancy Unit (EPU) with a confirmed single ongoing intrauterine pregnancy under 12 weeks' gestation. Participants will be randomly allocated in a 1:1 ratio to either receive their personalised miscarriage risk score (intervention group) or to receive standard care without disclosure of such a score (control group).
Randomisation will be implemented using a computer-generated allocation sequence with appropriate allocation concealment to minimize selection bias. The personalised miscarriage risk score will be derived using a validated predictive model incorporating relevant clinical and ultrasound parameters routinely collected during EPU assessment. The methodology underlying the risk calculation will remain consistent across participants to ensure comparability and reproducibility.
Participants in the intervention arm will be provided with their individualised risk estimate in a standardised format, accompanied by a brief explanation to support interpretation. Care will be taken to ensure that the communication approach is clear, non-directive, and does not include additional counselling beyond standard clinical practice. Participants in the control arm will receive routine clinical information and follow-up as per standard EPU protocols, without access to the calculated risk score.
The primary objective of the study is to determine whether disclosure of a personalised miscarriage risk score influences patient-reported anxiety levels in early pregnancy, assessed using a validated questionnaires on Day 0 and Day 7. The secondary objective is patient acceptability of the study using qualitative feedback on Day 7.
- Conditions
- Early Pregnancy Bleeding
- Being tested
- Miscarriage prediction score, Will not receive miscarriage prediction score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miscarriage prediction scoreOther
Half of the patients will receive a uniquely calculated miscarriage prediction score based on symptoms and individual characteristics
Will not receive miscarriage prediction scoreOther
These patients will not receive a miscarriage prediction score
| Study group | Role | What they receive |
|---|---|---|
| Receive Miscarriage Prediction Score | Experimental | These participants will receive their miscarriage prediction score Receives: Other: Miscarriage prediction score |
| Will Not Receive Miscarriage Prediction Score | Experimental | These patients will not receive a Miscarriage Prediction Score Receives: Other: Will not receive miscarriage prediction score |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the psychological effects of the miscarriage prediction model
The study will measure patients' psychological wellbeing objectively using a composite psychological distress score. This composite score is derived by combining the Hospital Anxiety and Depression Scale (HADS) and Penn State Worry Questionnaire (PSWQ) scores.
The HADS score has a minimum score of 0 (Low Anxiety/Depression) and maximum score of 42 (High Anxiety/Depression).
The PSWQ has a minimum score of 16 (Low Worry) and a maximum score of 80 (High Worry).
The composite score will therefore have a minimum score of 16 (low psychological distress) and a maximum score of 122 (greater psychological distress).
These questionnaires will be completed on day 0 and day 7 by patients in both treatment arms and a composite score will be calculated.
Measured: 7 days
To measure the psychological effects of the miscarriage prediction model
The study will measure patients' psychological wellbeing objectively using the Penn State Worry Questionnaire (PSWQ) score. The Penn State Worry Questionnaire has a minimum score of 16 (Low Worry) and a maximum score of 80 (High Worry). This questionnaire will be completed on day 0 and day 7 by patients in both treatment arms.
Measured: 7 days
Secondary outcomes (1)
Acceptability of receiving miscarriage prediction score
Acceptability will be assessed by sending patients who receive a miscarriage prediction score the following questions:
- Did receiving the miscarriage prediction score help you feel more informed and prepared about your pregnancy outcome? (Yes/No, with an optional text box for further explanation.)
- Would you recommend that other women in early pregnancy receive a miscarriage prediction score as part of their care? (Yes/No, with an optional explanation.)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start29 May 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Pregnancy BleedingStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jackie Ross, FRCOG, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609602
- Sponsor's protocol ID
- 356805
- Acronym
- PEMPS
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share IPD. The informed consent obtained from participants and ethics approval does not include provisions for broad data sharing beyond the immediate research team. As such, making IPD available outside the scope of the original study would not align with the consent provided.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
- ClinicalTrials.gov ID
- NCT07609602
- Acronym / sponsor ID
- PEMPS / 356805
- Conditions
- Early Pregnancy Bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 May 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.
Patients Under 12 Weeks Pregnant With a Single Ongoing Pregnancy Attending the EPU Will be Randomly Assigned to Receive Their Personalised Miscarriage Risk Score or Not. The Study Explores Whether Sharing This Score Affects Anxiety and Whether Patients Find the Information Helpful and Acceptable. (PEMPS)
Detailed description
The PEMPS study is a prospective, randomised controlled investigation designed to evaluate the psychological impact of providing individualised miscarriage risk estimates to patients in early pregnancy. The study population comprises individuals attending an Early Pregnancy Unit (EPU) with a confirmed single ongoing intrauterine pregnancy under 12 weeks' gestation. Participants will be randomly allocated in a 1:1 ratio to either receive their personalised miscarriage risk score (intervention group) or to receive standard care without disclosure of such a score (control group).
Randomisation will be implemented using a computer-generated allocation sequence with appropriate allocation concealment to minimize selection bias. The personalised miscarriage risk score will be derived using a validated predictive model incorporating relevant clinical and ultrasound parameters routinely collected during EPU assessment. The methodology underlying the risk calculation will remain consistent across participants to ensure comparability and reproducibility.
Participants in the intervention arm will be provided with their individualised risk estimate in a standardised format, accompanied by a brief explanation to support interpretation. Care will be taken to ensure that the communication approach is clear, non-directive, and does not include additional counselling beyond standard clinical practice. Participants in the control arm will receive routine clinical information and follow-up as per standard EPU protocols, without access to the calculated risk score.
The primary objective of the study is to determine whether disclosure of a personalised miscarriage risk score influences patient-reported anxiety levels in early pregnancy, assessed using a validated questionnaires on Day 0 and Day 7. The secondary objective is patient acceptability of the study using qualitative feedback on Day 7.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive Miscarriage Prediction Score | Experimental | Other: Miscarriage prediction scoreThese participants will receive their miscarriage prediction score |
| Will Not Receive Miscarriage Prediction Score | Experimental | Other: Will not receive miscarriage prediction scoreThese patients will not receive a Miscarriage Prediction Score |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Miscarriage prediction scoreHalf of the patients will receive a uniquely calculated miscarriage prediction score based on symptoms and individual characteristics | Other | Receive Miscarriage Prediction Score |
| Will not receive miscarriage prediction scoreThese patients will not receive a miscarriage prediction score | Other | Will Not Receive Miscarriage Prediction Score |
Primary outcome
To measure the psychological effects of the miscarriage prediction model
Time frame: 7 days
The study will measure patients' psychological wellbeing objectively using a composite psychological distress score. This composite score is derived by combining the Hospital Anxiety and Depression Scale (HADS) and Penn State Worry Questionnaire (PSWQ) scores. The HADS score has a minimum score of 0 (Low Anxiety/Depression) and maximum score of 42 (High Anxiety/Depression). The PSWQ has a minimum score of 16 (Low Worry) and a maximum score of 80 (High Worry). The composite score will therefore have a minimum score of 16 (low psychological distress) and a maximum score of 122 (greater psychological distress). These questionnaires will be completed on day 0 and day 7 by patients in both treatment arms and a composite score will be calculated.
To measure the psychological effects of the miscarriage prediction model
Time frame: 7 days
The study will measure patients' psychological wellbeing objectively using the Penn State Worry Questionnaire (PSWQ) score. The Penn State Worry Questionnaire has a minimum score of 16 (Low Worry) and a maximum score of 80 (High Worry). This questionnaire will be completed on day 0 and day 7 by patients in both treatment arms.
1 secondary outcome
Acceptability of receiving miscarriage prediction score
Time frame: 7 days
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 29 Oct 2026.
- Individual participant dataSharing planned: No. The investigators do not plan to share IPD. The informed consent obtained from participants and ethics approval does not include provisions for broad data sharing beyond the immediate research team. As such, making IPD available outside the scope of the original study would not align with the consent provided.
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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.
Jackie Ross contact
Jackie Ross, FRCOG principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miscarriage prediction score and Will not receive miscarriage prediction score in people with Early Pregnancy Bleeding, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 4 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: looking for participants now, as of the sponsor's last update on 29 Oct 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 United Kingdom. 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 Eleanor Fleming, MBBS BSc MRCOG (+4420 3299 3168, eleanor.fleming@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the psychological effects of the miscarriage prediction model (time frame: 7 days). 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 29 Oct 2026.