The Psychological Effects of Miscarriage Prediction Score: A Prospective Study

Обзор

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)

Подробное описание

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.

Вмешательства

• Другое Miscarriage prediction score
  Half of the patients will receive a uniquely calculated miscarriage prediction score based on symptoms and individual characteristics
• Другое Will not receive miscarriage prediction score
  These patients will not receive a miscarriage prediction score

Первичные конечные точки

• To measure the psychological effects of the miscarriage prediction model [Срок оценки: 7 days]
• To measure the psychological effects of the miscarriage prediction model [Срок оценки: 7 days]

Вторичные конечные точки (1)

• Acceptability of receiving miscarriage prediction score [Срок оценки: 7 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07609602 · 356805

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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