The Tommy's National Rainbow Clinic Study

ConditionStillbirth
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age16-50
SponsorUniversity of Manchester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Less than 16 years of age

Anyone who lacks capacity to consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rainbow Clinic Model of Antenatal Care

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Participants1 intervention

Trial outcomes

Primary outcomes

1

Gestation of birth

Gestation at birth in present pregnancy

Time frame
At birth
2

Mode of birth

Mode of delivery in present pregnancy

Time frame
At birth
3

Admission to Neonatal Unit

Admission to neonatal unit following delivery of the baby

Time frame
At birth
4

Birthweight

Recorded weight at birth

Time frame
At birth

Secondary outcomes

1

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).

Time frame
17 and 36 weeks' gestation
2

Maternal Depression

Depression as assessed by Edinburgh Postnatal Depression Score (Lowest score 0 and Highest Score 30, Higher score = greater depression).

Time frame
17 and 36 weeks' gestation

Other outcomes

1

Women's experience of care

Measured by bespoke patient experience questionnaire

Time frame
36 weeks' gestation

Sponsors and contacts

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