The Psychological Effects of Miscarriage Prediction Score: A Prospective Study (PEMPS)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Eleanor Fleming, MBBS BSc MRCOG
- Telefoonnummer: +4420 3299 3168
- E-mail: eleanor.fleming@nhs.net
Studie Contact Back-up
- Naam: Jackie Ross
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Receive Miscarriage Prediction Score
These participants will receive their miscarriage prediction score
|
Half of the patients will receive a uniquely calculated miscarriage prediction score based on symptoms and individual characteristics
|
|
Experimenteel: Will Not Receive Miscarriage Prediction Score
These patients will not receive a Miscarriage Prediction Score
|
These patients will not receive a miscarriage prediction score
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
To measure the psychological effects of the miscarriage prediction model
Tijdsspanne: 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. |
7 days
|
|
To measure the psychological effects of the miscarriage prediction model
Tijdsspanne: 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.
|
7 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Acceptability of receiving miscarriage prediction score
Tijdsspanne: 7 days
|
Acceptability will be assessed by sending patients who receive a miscarriage prediction score the following questions:
|
7 days
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jackie Ross, FRCOG, King's College Hospital NHS Trust
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 356805
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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