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The Tommy's National Rainbow Clinic Study

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated March 16, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Re-verified, no change to tracked fieldsv8
  2. Notable Primary completion date: Sep 30, 2025 to Sep 30, 2026
    • Study completion date: Sep 30, 2026 to Sep 30, 2027
    • Site contact updated
    v7
  3. Minor Site contact updatedv6
  4. Minor 2 versions Re-verified since May 16, 2022, no change to tracked fieldsv4-v5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 1, 2020 to Dec 1, 2020
    v3
  6. Notable Start date: Sep 1, 2020 to Nov 1, 2020
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 3 words
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04393259
Lead Sponsor University of Manchester
Conditions
(from sponsor)
Stillbirth
Related terms Anxiety Disorders, Depression, Stillbirth
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov