- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04393259
The Tommy's National Rainbow Clinic Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alexander E Heazell, PhD
- Phone Number: +441612766484
- Email: alexander.heazell@manchester.ac.uk
Study Contact Backup
- Name: Emma Tomlinson, RM
- Phone Number: +4416170106965
- Email: emma.tomlinson@mft.nhs.uk
Study Locations
-
-
Greater Manchester
-
Manchester, Greater Manchester, United Kingdom, M13 9WL
- Recruiting
- Manchester University NHS Foundation Trust
-
Contact:
- Emma Tomlinson, RM
- Email: emma.tomlinson@mft.nhs.uk
-
Principal Investigator:
- Alexander Heazell, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants
Women attending an antenatal service using the Rainbow Clinic model of care.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gestation of birth
Time Frame: At birth
|
Gestation at birth in present pregnancy
|
At birth
|
Mode of birth
Time Frame: At birth
|
Mode of delivery in present pregnancy
|
At birth
|
Admission to Neonatal Unit
Time Frame: At birth
|
Admission to neonatal unit following delivery of the baby
|
At birth
|
Birthweight
Time Frame: At birth
|
Recorded weight at birth
|
At birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Anxiety
Time Frame: 17 and 36 weeks' gestation
|
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).
|
17 and 36 weeks' gestation
|
Maternal Depression
Time Frame: 17 and 36 weeks' gestation
|
Depression as assessed by Edinburgh Postnatal Depression Score (Lowest score 0 and Highest Score 30, Higher score = greater depression).
|
17 and 36 weeks' gestation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Women's experience of care
Time Frame: 36 weeks' gestation
|
Measured by bespoke patient experience questionnaire
|
36 weeks' gestation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS249991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stillbirth
-
Hawler Medical UniversityCompletedUnexplained StillbirthIraq
-
Centre Hospitalier Universitaire de NīmesCompletedCaesarean Section;Stillbirth
-
Università degli Studi dell'InsubriaNot yet recruitingPregnancy Complications | Delivery;Abnormal;Stillbirth
-
Hacettepe UniversityRecruitingPain | Breastfeeding | Caesarean Section;StillbirthTurkey
-
Policlinico HospitalUnknownMicrobial Colonization | Caesarean Section;StillbirthItaly
-
Centre Hospitalier Universitaire de BesanconCompletedTermination of Pregnancy | Neonatal Death | Stillbirth and Fetal DeathFrance
-
NICHD Global Network for Women's and Children's...CompletedMaternal Morbidity and Mortality | Stillbirth and Neonatal MortalityZambia, India, Pakistan, Kenya, Guatemala, Argentina
-
University of ManchesterUniversity of Leeds; University of Birmingham; University of LeicesterRecruitingPerinatal Death | Stillbirth and Fetal DeathUnited Kingdom
-
Cukurova UniversityEnrolling by invitationCaesarean Section;Stillbirth | Postpartum ComplicationTurkey
-
Balikesir UniversityCompletedDelivery;Breech;StillbirthTurkey
Clinical Trials on Rainbow Clinic Model of Antenatal Care
-
Showa UniversityIndonesia UniversityUnknownPregnant Women | Preterm Delivery | Antenatal Care ModelIndonesia
-
Janssen Scientific Affairs, LLCCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Public Health Foundation of IndiaLondon School of Hygiene and Tropical Medicine; Kathmandu University School...Not yet recruitingAnemia | Gestational Diabetes Mellitus (GDM) | Pregnancy Induced Hypertension (PIH)India, Nepal
-
Yale UniversityAmerican Cancer Society, Inc.CompletedChildhood Cancer
-
St Vincent's Hospital MelbourneCompletedFunctional Dyspepsia | Irritable Bowel Syndrome | Constipation - Functional | Faecal Incontinence | Functional Abdominal Pain Syndrome | Other Rome IV Functional Gastrointestinal DisordersAustralia
-
Foundation for Professional Development (Pty) LtdNational Institute of Allergy and Infectious Diseases (NIAID); University of... and other collaboratorsRecruitingHIV/AIDS | Pregnancy | Cost-effectiveness | Antenatal Care | Chlamydia Trachomatis | Vaginal Microbiome | Birth Outcomes | Sexually Transmitted Infection | Neisseria Gonorrhoeae | Trichomonas VaginalisSouth Africa
-
The University of Texas Health Science Center,...TerminatedAmniotic Fluid; Disorder | Fetal Growth AbnormalityUnited States
-
University Health Network, TorontoCompleted
-
Macfarlane Burnet Institute for Medical Research...National Health and Medical Research Council, Australia; Gilead Sciences; The... and other collaboratorsRecruitingHepatitis C | Hepatitis C, Chronic | Chronic Hepatitis cAustralia
-
Nationwide Children's HospitalCompletedLow Back Pain | Spondylolisthesis | SpondylolysisUnited States