StillbirthNCT04393259
The Tommy's National Rainbow Clinic Study
An observational study of Stillbirth, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Stillbirth
- What is being tested?
- Rainbow Clinic Model of Antenatal Care
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2020to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant women once booked for antenatal care, will be eligible for the study if they are attending the Rainbow clinic or equivalent service at one of the recruiting sites across the country.
Who may be able to join
- 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
Who cannot join
- Less than 16 years of age
- Anyone who lacks capacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL
Emma Tomlinson, RM, emma.tomlinson@mft.nhs.uk
Alexander Heazell, PhD
About this study
Official title: The Tommy's National Rainbow Clinic Study: Evaluation of a Specialist Antenatal Service for Women and Families Following a Stillbirth or Neonatal Death
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.
Read the detailed description
In the UK, 1 in 300 parents will experience a stillbirth each year, which is over 2,700 babies per year (Manktelow, Smith et al. 2016). There are also over 1,250 neonatal deaths per year, meaning there are approximately 4,000 bereaved families per year in the UK. The death of a baby before or shortly after birth is a profoundly distressing experience for women and their families and is invariably followed by a period of protracted grief (Heazell, Siassakos et al. 2016). Previous stillbirth or neonatal death is consistently recognised to increase parents' anxiety, emotional vulnerability and decrease confidence in the next pregnancy (Mills, Ricklesford et al. 2014). This is a cause for concern because studies in the general maternity population have suggested that elevated maternal anxiety increases the risk of adverse pregnancy outcomes, notably preterm birth and low birthweight (Black, Shetty et al. 2008). A recent UK longitudinal study reported that the negative psychological impacts of perinatal loss persist far beyond the next pregnancy and despite the birth of a healthy child (Blackmore et al., 2011). This may have significant long term effects on outcomes for subsequent children; previous history of stillbirth or neonatal death has been reported to disrupt maternal attachment and negatively impact on parenting (Warland, O'Leary et al. 2011). Many parents feel robbed of the 'normal' positive feelings they expected and have described to us how their subsequent pregnancies were characterised by heightened anxiety and fear (Mills, Ricklesford et al. 2014). Common misconceptions, such as the belief that a new pregnancy helps to 'get over' grief for a lost child, effectively isolates parents from social support networks, increasing reliance on external and professional intervention.
Qualitative studies of women's experiences of subsequent pregnancies highlight the value placed on regular interaction with health professionals (Côté-Arsenault, Donato et al. 2006, Côté-Arsenault 2007, Cote-Arsenault and Donato 2011). This evidence suggests that specialist antenatal support might ameliorate anxiety, improve experiences of pregnancy, support relationships and positively impact on future parenthood (Caelli, Downie et al. 2002). However, there is a dearth of evidence regarding what additional antenatal support parents' desire following a previous stillbirth or neonatal death.
To address the need for increased antenatal surveillance and support the Rainbow Clinic was established in St Mary's Hospital, Manchester in 2013 and rolled out in a neighbouring hospital in Manchester in 2016. An extensive quality improvement project and accompanying research study demonstrated that attendance at the Rainbow clinic improved pregnancy outcomes, decreased anxiety levels and was associated with a social value of £6.10 for each £1 invested. The investigators are now working to establish Rainbow Clinics in other maternity units. As this is a new clinical service there is a need to evaluate the care provided in the Rainbow clinics across the United Kingdom, to look at women's experiences of care, where care can be improved and its impact upon pregnancy outcomes for mothers and babies. This needs information about pregnancy outcomes and women's experiences. Participation in this research study will allow us to collect and aggregate this information.
- Conditions
- Stillbirth
- Being tested
- Rainbow Clinic Model of Antenatal Care
- Keywords
- Pregnancy after loss, Antenatal care, Anxiety, Depression
- Medical subject headings
- Stillbirth, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rainbow Clinic Model of Antenatal CareOther
Rainbow Clinic Model is an antenatal model of care with initial ultrasound scan at 23 weeks' gestation including uterine artery Doppler, frequency of subsequent scans determined using data from this initial scan. Continuity of care is provided by obstetricians and midwives.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Women attending an antenatal service using the Rainbow Clinic model of care. Receives: Other: Rainbow Clinic Model of Antenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestation of birth
Gestation at birth in present pregnancy
Measured: At birth
Mode of birth
Mode of delivery in present pregnancy
Measured: At birth
Admission to Neonatal Unit
Admission to neonatal unit following delivery of the baby
Measured: At birth
Birthweight
Recorded weight at birth
Measured: At birth
Secondary outcomes (2)
Maternal Anxiety
Anxiety as assessed by Generalised Anxiety Disorder (2-item) (Lowest score 0 and Highest score 6, Higher score = more anxiety) and Cambridge Worry Score (Lowest score 0 and Highest score 85, Higher score = more worry).
Measured: 17 and 36 weeks' gestation
Maternal Depression
Depression as assessed by Edinburgh Postnatal Depression Score (Lowest score 0 and Highest Score 30, Higher score = greater depression).
Measured: 17 and 36 weeks' gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Dec 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Alexander Heazell, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393259
- Sponsor's protocol ID
- IRAS249991
- Status last verified
- Mar 2026
- First submitted
- 13 May 2020
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD plan
Publications
Barron RL, Tomlinson E, Bailey E, Heazell AE. 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. BMJ Open. 2025 Aug 5;15(8):e103294. doi: 10.1136/bmjopen-2025-103294.
PubMed 40764070
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tommy's National Rainbow Clinic Study: Evaluation of a Specialist Antenatal Service for Women and Families Following a Stillbirth or Neonatal Death
- ClinicalTrials.gov ID
- NCT04393259
- Acronym / sponsor ID
- IRAS249991
- Conditions
- Stillbirth
- Keywords
- Pregnancy after loss, Antenatal care, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the UK, 1 in 300 parents will experience a stillbirth each year, which is over 2,700 babies per year (Manktelow, Smith et al. 2016). There are also over 1,250 neonatal deaths per year, meaning there are approximately 4,000 bereaved families per year in the UK. The death of a baby before or shortly after birth is a profoundly distressing experience for women and their families and is invariably followed by a period of protracted grief (Heazell, Siassakos et al. 2016). Previous stillbirth or neonatal death is consistently recognised to increase parents' anxiety, emotional vulnerability and decrease confidence in the next pregnancy (Mills, Ricklesford et al. 2014). This is a cause for concern because studies in the general maternity population have suggested that elevated maternal anxiety increases the risk of adverse pregnancy outcomes, notably preterm birth and low birthweight (Black, Shetty et al. 2008). A recent UK longitudinal study reported that the negative psychological impacts of perinatal loss persist far beyond the next pregnancy and despite the birth of a healthy child (Blackmore et al., 2011). This may have significant long term effects on outcomes for subsequent children; previous history of stillbirth or neonatal death has been reported to disrupt maternal attachment and negatively impact on parenting (Warland, O'Leary et al. 2011). Many parents feel robbed of the 'normal' positive feelings they expected and have described to us how their subsequent pregnancies were characterised by heightened anxiety and fear (Mills, Ricklesford et al. 2014). Common misconceptions, such as the belief that a new pregnancy helps to 'get over' grief for a lost child, effectively isolates parents from social support networks, increasing reliance on external and professional intervention.
Qualitative studies of women's experiences of subsequent pregnancies highlight the value placed on regular interaction with health professionals (Côté-Arsenault, Donato et al. 2006, Côté-Arsenault 2007, Cote-Arsenault and Donato 2011). This evidence suggests that specialist antenatal support might ameliorate anxiety, improve experiences of pregnancy, support relationships and positively impact on future parenthood (Caelli, Downie et al. 2002). However, there is a dearth of evidence regarding what additional antenatal support parents' desire following a previous stillbirth or neonatal death.
To address the need for increased antenatal surveillance and support the Rainbow Clinic was established in St Mary's Hospital, Manchester in 2013 and rolled out in a neighbouring hospital in Manchester in 2016. An extensive quality improvement project and accompanying research study demonstrated that attendance at the Rainbow clinic improved pregnancy outcomes, decreased anxiety levels and was associated with a social value of £6.10 for each £1 invested. The investigators are now working to establish Rainbow Clinics in other maternity units. As this is a new clinical service there is a need to evaluate the care provided in the Rainbow clinics across the United Kingdom, to look at women's experiences of care, where care can be improved and its impact upon pregnancy outcomes for mothers and babies. This needs information about pregnancy outcomes and women's experiences. Participation in this research study will allow us to collect and aggregate this information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Rainbow Clinic Model of Antenatal CareWomen attending an antenatal service using the Rainbow Clinic model of care. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women once booked for antenatal care, will be eligible for the study if they are attending the Rainbow clinic or equivalent service at one of the recruiting sites across the country.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Less than 16 years of age
- Anyone who lacks capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rainbow Clinic Model of Antenatal CareRainbow Clinic Model is an antenatal model of care with initial ultrasound scan at 23 weeks' gestation including uterine artery Doppler, frequency of subsequent scans determined using data from this initial scan. Continuity of care is provided by obstetricians and midwives. | Other | Participants |
Primary outcome
Gestation of birth
Time frame: At birth
Gestation at birth in present pregnancy
Mode of birth
Time frame: At birth
Mode of delivery in present pregnancy
Admission to Neonatal Unit
Time frame: At birth
Admission to neonatal unit following delivery of the baby
Birthweight
Time frame: At birth
Recorded weight at birth
2 secondary outcomes
Maternal Anxiety
Time frame: 17 and 36 weeks' gestation
Maternal Depression
Time frame: 17 and 36 weeks' gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 40764070Barron RL, Tomlinson E, Bailey E, Heazell AE. 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. BMJ Open. 2025 Aug 5;15(8):e103294. doi: 10.1136/bmjopen-2025-103294.
- Individual participant dataSharing planned: No. No IPD plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stillbirth, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander E Heazell, PhD (+441612766484, alexander.heazell@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestation of birth (time frame: At birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.