NCT04393259 The Tommy's National Rainbow Clinic Study
| NCT ID | NCT04393259 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manchester |
| Condition | Stillbirth |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2020-12-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The death of a baby before or shortly after birth affects approximately 1 in every 250 pregnancies in the UK meaning that over 4,000 parents experience the death of a baby each year in the UK. The majority of women who have experienced the loss of a baby will have another pregnancy, usually within a year. Our analysis of 14 studies concluded that parents need specialist support from doctors and midwives in a future pregnancy to reduce the risk of pregnancy complications and to provide the care and support they need. The Rainbow Clinic model aims to provide specialist care and support to families who have experienced the death of a baby during pregnancy or shortly afterwards. Rainbow Clinic was initially established in St Mary's Hospital, Manchester in 2013. The Rainbow Clinic team are now working to establish Rainbow Clinics in other maternity units throughout the UK. As this is a new clinical service the investigators would like to evaluate the care provided in the Rainbow clinics across the United Kingdom, to look at women's experiences of care, their levels of anxiety and depression, to identify where care can be improved and the pregnancy outcomes of women attending Rainbow Clinic. This evaluation needs information about pregnancy outcomes and women's experiences. Participation in this research study will allow us to collect and aggregate this information. The investigators will ask all women attending participating Rainbow Clinics to complete a short questionnaire early in their pregnancy and again at the end. The study will collect information about the outcome of their pregnancy.
Eligibility Criteria
Inclusion Criteria: * Women who are attending the Rainbow Clinic because they have had prior stillbirth, neonatal death or late termination of pregnancy * Women who are currently pregnant Exclusion Criteria: * Less than 16 years of age * Anyone who lacks capacity to consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04393259 clinical trial?
This trial is open to female participants only, aged 16 Years or older, up to 50 Years, studying Stillbirth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04393259 currently recruiting?
Yes, NCT04393259 is actively recruiting participants. Contact the research team at alexander.heazell@manchester.ac.uk for enrollment information.
Where is the NCT04393259 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT04393259 clinical trial?
NCT04393259 is sponsored by University of Manchester. The trial plans to enroll 500 participants.