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NCT07609602
The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
Conditions: Early Pregnancy Bleeding
Sex: Female
Ages: 16 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 372
Sponsor: King's College Hospital NHS Trust
Location: King's College Hospital London
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)
Eligibility 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.
Source: ClinicalTrials.gov (NCT07609602). StuddyBuddy aggregates publicly available trial information.