Specialized care for parents after stillbirth or neonatal death
The Tommy's National Rainbow Clinic Study: Evaluation of a Specialist Antenatal Service for Women and Families Following a Stillbirth or Neonatal Death
This study is testing a special care program for parents who have experienced stillbirth or neonatal death to see if it helps reduce anxiety and improve their next pregnancy outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Manchester Academic / other |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT04393259 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the Rainbow Clinic model, which provides specialized antenatal care for women who have previously experienced stillbirth, neonatal death, or late termination of pregnancy. The study aims to assess the effectiveness of this model in reducing anxiety and improving outcomes in subsequent pregnancies. By analyzing the care provided at Rainbow Clinics established across the UK, the research seeks to understand the impact of tailored support on maternal mental health and pregnancy outcomes. The initiative is based on previous findings that highlight the need for specialized support to mitigate the psychological effects of perinatal loss.
Who should consider this trial
Good fit: Ideal candidates for this study are women who are currently pregnant and have a history of stillbirth, neonatal death, or late termination of pregnancy.
Not a fit: Patients who are under 16 years of age or those who lack the capacity to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the mental health and pregnancy outcomes for women who have experienced previous losses.
How similar studies have performed: Previous studies have indicated the necessity for specialized support in similar contexts, suggesting that this approach may yield positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Manchester, Greater Manchester
- Manchester University NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Alexander E Heazell, PhD
- Email: alexander.heazell@manchester.ac.uk
- Phone: +441612766484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.