NCT03231007 (SPiRE) is a clinical trial of Questionnaire in Stillbirth, sponsored by University of Manchester.

Who is sponsoring NCT03231007?

NCT03231007 is sponsored by University of Manchester.

What drugs are being tested in NCT03231007?

Interventions in NCT03231007: Questionnaire.

What condition does NCT03231007 study?

NCT03231007 studies Stillbirth.

Is NCT03231007 still recruiting?

NCT03231007 is currently completed. Last updated 4 December 2018.

Last reviewed 2018-12-04 · How we verify

NCT03231007: SPiRE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study

Completed Last updated 4 December 2018

What this trial tests

trial testing Questionnaire in Stillbirth in 4,952 participants. Completed in 5 July 2018.

Timeline

10 July 2017

Primary endpoint
28 February 2018

5 July 2018

Quick facts

Lead sponsor	University of Manchester
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4,952
Start date	10 July 2017
Primary completion	28 February 2018
Estimated completion	5 July 2018
Sites	20 locations across United Kingdom

Drugs / interventions tested

Questionnaire

Conditions studied

Stillbirth — all drugs for Stillbirth →

Sponsor

University of Manchester

Who can join

16 and older, any sex, with Stillbirth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a multicentre evaluation of maternity care delivered through the Saving Babies' Lives care bundle using both quantitative and qualitative methodologies. The study will be conducted in twenty NHS Hospital Trusts from six NHS Strategic Clinical Networks totalling approximately 100,000 births. It involves participation by both service users and care providers. To determine the impact of the care bundle on pregnancy outcomes, birth data and other clinical measures will be extracted from maternity databases and case-note audit from before and after implementation. Additionally, this study will employ questionnaires with organisational leads and review clinical guidelines to assess how resources, leadership and governance may affect implementation in diverse hospital settings. The cost of implementing the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a health economic analysis. The views and experiences of service users and service providers towards maternity care in relation to the care bundle will be also be sought using questionnaires. This study will provide practice-based evidence to advance knowledge about the processes that underpin successful implementation of the care bundle so that it can be further developed and refined. This has the potential to translate into substantial improvements in the rate of late stillbirth in the UK should the care bundle be proved effective.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Stillbirth rates, service outcomes and costs of implementing NHS England's Saving Babies' Lives care bundle in maternity units in England: A cohort study.
Widdows K, Roberts SA, Camacho EM, Heazell AEP. · · 2021 · cited 25× · PMID 33872334 · DOI 10.1371/journal.pone.0250150
Saving babies' lives project impact and results evaluation (SPiRE): a mixed methodology study.
Widdows K, Reid HE, Roberts SA, Camacho EM, et al · · 2018 · cited 20× · PMID 29378526 · DOI 10.1186/s12884-018-1672-x
Assessment of the quality, content and perceived utility of local maternity guidelines in hospitals in England implementing the saving babies' lives care bundle to reduce stillbirth.
Lau YZ, Widdows K, Roberts SA, Khizar S, et al · · 2020 · cited 11× · PMID 32327423 · DOI 10.1136/bmjoq-2019-000756

Verify or expand the search:

Other recruiting trials for Stillbirth

Currently open trials in the same condition.

NCT06125860 — BEP Targeting Strategies in Ethiopia · NA · recruiting
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NCT04393259 — The Tommy's National Rainbow Clinic Study · recruiting
NCT03775954 — Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise · recruiting
NCT03662178 — Investigating the Structured Use of Ultrasound Scanning for Fetal Growth · recruiting

Other University of Manchester trials

Trials by the same sponsor.

NCT07506096 — Using IF-THEN Plans to Support Healthcare Professionals in Raising Patient Safety Concerns · NA · not yet recruiting
NCT07084090 — Using IF-THEN Plans to Support Patients in Raising Safety Concerns About Their Care · NA · not yet recruiting
NCT07494760 — A Feasibility Randomised Control Trial to Evaluate Early Perinatal Bereavement Counselling for Parents Who Have Experien · NA · not yet recruiting
NCT07372885 — GRanulocyte Augmented Cord Blood Transplantation for Poor Risk leukaEmia · Phase 1, PHASE2 · not yet recruiting
NCT07381894 — Multicentre Hypertrophic Cardiomyopathy Registry · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03231007 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Manchester
Last refreshed: 4 December 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03231007.

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