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NCT04393259
The Tommy's National Rainbow Clinic Study
trial testing Rainbow Clinic Model of Antenatal Care in Stillbirth in 500 participants. Currently enrolling.
30 September 2026
Quick facts
| Lead sponsor | University of Manchester |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 1 December 2020 |
| Primary completion | 30 September 2026 |
| Estimated completion | 30 September 2027 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Rainbow Clinic Model of Antenatal Care
Conditions studied
- Stillbirth — all drugs for Stillbirth →
Sponsor
University of Manchester
Who can join
Adults 16 to 50, female only, with Stillbirth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Tommy's National Rainbow Clinic Study: a protocol for a multi-site cohort study to evaluate a specialist antenatal service for women and families following a stillbirth or neonatal death.
Barron RL, Tomlinson E, Bailey E, Heazell AE. · · 2025 · PMID 40764070 · DOI 10.1136/bmjopen-2025-103294
Verify or expand the search:
- PubMed search for NCT04393259
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Manchester trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04393259 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Manchester
- Last refreshed: 16 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04393259.
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