A cohort study in couples who have suffered miscarriage with assessment of future pregnancy outcome
Miscarriage
Current interventions as of 22/10/2025: Potential participants (which may or may not include couples) will be referred to a miscarriage clinic by their GP or self-refer. The site can provide an information letter by paper or online via email and/or text, but email will be used wherever possible. The local research team (care team) may provide information regarding standard care NHS services, along with a link to the online study patient information sheet (PIS), enrolment form and consent form. To gain a better understanding of the impact that male factors, especially sperm, play in miscarriage risk, partners will have the same opportunity to enrol in the study. Not all partners are male, and not all partners are biologically linked to a pregnancy. In this context, the term 'partner' refers to the person whose sperm was involved in the pregnancies. Once the enrolment form and consent form have been completed, the participant and partner (where applicable) will be able to access the baseline questionnaire. The baseline questionnaire documents the health and pregnancy status and any standard care received up to this point. A follow-up questionnaire is six-monthly after the date of the baseline questionnaire and completed by participants and partners (where applicable) up to 5 years. The follow-up questionnaire will document further reproductive treatment and pregnancy outcomes. The data will be stored in a secure study database held on Birmingham Clinical Trials Unit (BCTU) servers, University of Birmingham. All existing relevant investigation results may be imported or input into the database from existing hospital systems Personal data recorded on all documents will be regarded as strictly confidential and will be handled and stored in accordance with the Data Protection Act 2018 (and subsequent amendments). The baby’s NHS number and future relevant contact with the participant (or partner, where applicable) will be requested through appropriate consent so that
Current key inclusion criteria as of 22/10/2025: 1. History of one or more pregnancy losses 2. Aged 16 years or over 3. Actively trying to become pregnant 4. Willing and able to provide consent _____ Previous key inclusion criteria: 1. Couples with a history of one or more pregnancy losses 2. Aged 18-55 years
Current key exclusion criteria as of 22/10/2025: Decline to consent to having their information stored _____ Previous key exclusion criteria: Couples who decline to give consent