The Psychological Effects of Miscarriage Prediction Score: A Prospective Study

NCT07609602 | Not Yet Recruiting

• 1 other identifier: 356805
• Study Type: interventional
• Target: 372
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Early Pregnancy Bleeding

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  7 days

Secondary Outcomes (1)

• Acceptability of receiving miscarriage prediction score

  7 days

Study Arms (2)

Receive Miscarriage Prediction Score

EXPERIMENTAL

These participants will receive their miscarriage prediction score

Other: Miscarriage prediction score

Will Not Receive Miscarriage Prediction Score

EXPERIMENTAL

These patients will not receive a Miscarriage Prediction Score

Other: Will not receive miscarriage prediction score

Interventions

Miscarriage prediction score OTHER

Half of the patients will receive a uniquely calculated miscarriage prediction score based on symptoms and individual characteristics

Receive Miscarriage Prediction Score

Will not receive miscarriage prediction score OTHER

These patients will not receive a miscarriage prediction score

Will Not Receive Miscarriage Prediction Score

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Officials

• Jackie Ross, FRCOG

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleanor Fleming, MBBS BSc MRCOG

CONTACT

+4420 3299 3168; eleanor.fleming@nhs.net

Jackie Ross

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share