Clinical trial Recruiting at 1 site Observational Ages 16 to 50 Women only

Specialized care for parents after stillbirth or neonatal death

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

Run by University of Manchester · NCT04393259 · Data updated 2026-11-12

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 typeObservational
Ages16 Years to 50 Years
SexWomen only
Enrollment500 (estimated)
SponsorUniversity of Manchester
Academic / other
Locations1 site (Manchester, Greater Manchester)
StatusRecruiting
StartedDecember 1, 2020
Main results expectedSeptember 30, 2026
Study endsSeptember 30, 2027
Registry record updatedMarch 16, 2026
Trial IDNCT04393259 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have indicated the necessity for specialized support in similar contexts, suggesting that this approach may yield positive outcomes.

Who can join: the full rules

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 it's running

  • Manchester University NHS Foundation Trust
    Manchester, Greater Manchester, United Kingdom
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.