Evidence map›Paper›PMID 39260866›Full record

ArticleBMJ open2024

PRECIOUS study (PREterm Caesarean/vaginal birth and IVH/OUtcomeS): does mode of birth reduce the risk of death or brain injury in very preterm babies? A cohort and emulated target trial protocol.

David Odd, Nicola F Reeve, Jane Barnett, Judith Cutter, Rhian Daniel, Chris Gale, Dimitris Siasakos

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

David OddUniversity Hospital of Wales, Cardiff, UK OddD@cardiff.ac.uk.ORCID 0000-0002-6416-4966
Nicola F ReeveCardiff University, Cardiff, UK.ORCID 0000-0001-9602-6675
Jane BarnettPatient Representative, Cardiff, UK.
Judith CutterCardiff and Vale University Health Board, Cardiff, UK.
Rhian DanielCardiff University, Cardiff, UK.
Chris GaleNeonatal Medicine, School of Public Health, Imperial College London, London, UK.ORCID 0000-0003-0707-876X
Dimitris SiasakosUCL EGA Institute for Women's Health, UCL, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVery preterm babies are at risk of poor neurodevelopmental outcomes and death. Intraventricular haemorrhage (IVH) after birth is the most prevalent cause of this. Birth by caesarean section may protect against IVH in very preterm babies, but the evidence is limited. The aim is to identify and obtain the quantitative evidence needed to inform a future definitive clinical trial to determine the optimal mode of delivery in preterm birth. METHODS AND ANALYSIS: We will use three broad workstreams (WS) to answer complementary questions. WSs 1 and 2 involve the analysis of routinely recorded national clinical data held in an established research database. In WS1 (October 2023-March 2024), we will use conventional methods to identify what is needed to undertake a trial: the population of interest, areas of equipoise and a plausible range of effect sizes. In WS2 (April 2024-October 2024), using an emulated target trial framework, we will attempt to make inferences about the treatment effect from such a future trial and will identify potential challenges in recruitment and estimate likely 'intention-to-treat' versus 'per-protocol' profiles; these analyses will also be useful for power calculations for future possible trials. In WS3 (October 2024-March 2025), we will convene a consensus meeting with key stakeholders, supported by a clinical trials unit, to develop a multicentre clinical trial to identify the optimal mode of birth for preterm deliveries. ETHICS AND DISSEMINATION: In this study, we will use deidentified data held in the National Neonatal Research Database (NNRD), an established national population database; parents can opt out of their baby's data being held in the NNRD. HRA/Health and Care Research Wales and National Health Service (NHS) study-specific Research Ethics Committee approval (London-Queen Square Research Ethics Committee) (Ref: 23/LO/0826) ethical approval has been obtained. Key outputs of the PRECIOUS (PREterm Caesarean/vaginal birth and IVH/OUutcomeS) study include the identification of the data, and accordingly of the multidisciplinary team required, to develop, gain funding and complete, a clinical trial to definitively identify the optimal mode of delivery for preterm infants and their mothers.

Indexed as

Cesarean SectionPremature BirthBrain InjuriesCerebral Intraventricular HemorrhageDelivery, ObstetricFemaleHumansInfant, Extremely PrematureInfant, NewbornInfant, PrematureObservational Studies as TopicPregnancyResearch DesignBrain InjuriesCesarean SectionEPIDEMIOLOGYNEONATOLOGYOBSTETRICS

Identifiers

PMID39260866
PMCPMC11409379

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.