The Tommy's National Rainbow Clinic Study

NCT04393259 | Recruiting

• 1 other identifier: IRAS249991
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Stillbirth

Keywords

Pregnancy after loss; Antenatal care; Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• Gestation of birth

  Gestation at birth in present pregnancy

  At birth

• Mode of birth

  Mode of delivery in present pregnancy

  At birth

• Admission to Neonatal Unit

  Admission to neonatal unit following delivery of the baby

  At birth

• Birthweight

  Recorded weight at birth

  At birth

Secondary Outcomes (2)

• Maternal Anxiety

  17 and 36 weeks' gestation

• Maternal Depression

  17 and 36 weeks' gestation

Other Outcomes (1)

• Women's experience of care

  36 weeks' gestation

Study Arms (1)

Participants

Women attending an antenatal service using the Rainbow Clinic model of care.

Other: Rainbow Clinic Model of Antenatal Care

Interventions

Rainbow Clinic Model of Antenatal Care OTHER

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.

Participants

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Less than 16 years of age
• Anyone who lacks capacity to consent

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 40764070 DERIVED

MeSH Terms

Conditions

Stillbirth; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Alexander E Heazell, PhD

CONTACT

+441612766484; alexander.heazell@manchester.ac.uk

Emma Tomlinson, RM

CONTACT

+4416170106965; emma.tomlinson@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: December 1, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)