Trial reportBMJ open2022
Corticosteroids to safely reduce neonatal respiratory morbidity after late preterm and term planned caesarean section birth? A randomised placebo-controlled feasibility study.
Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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.
Who cites it
1 citing paper in PubMed, 3 citations in OpenAlex.
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess the feasibility of conducting a randomised placebo-controlled trial of corticosteroids prior to planned caesarean section from 35
designA triple-blind, placebo-controlled, parallel, trial randomised at the participant level (1:1 ratio). Additional feasibility data obtained by questionnaires from trial participants and women who declined trial participation, and focus groups with local site researchers and clinicians.
settingThree obstetric units in New Zealand including tertiary and secondary care; public and private care, and research active and non-active units.
participantsWomen undergoing a planned caesarean section from 35
interventionsTwo doses of 11.4 mg betamethasone or saline placebo. Questionnaires and focus group meetings. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: trial recruitment rate of eligible women. SECONDARY OUTCOMES: trial recruitment by gestational age, site and delivery indication; proportion of babies who completed measurements of blood glucose concentrations as per protocol; overall incidence neonatal respiratory distress requiring >60 min of respiratory support; overall incidence of neonatal hypoglycaemia, and barriers and enablers to trial participation by participants, researchers and clinicians.
resultsThe recruitment rate was 8.9% (88/987) overall and 11.2% (88/789) for those approached about the trial. Neonatal blood glucose concentrations were measured as per protocol in 87/92 (94.6%) babies. For potential participants, key enablers to participation were contributing to research, a feeling of relevance and a good understanding; key barriers were a lack of understanding and concerns over safety. For researchers and clinicians, themes representing enablers and barriers included relevance, communication and awareness, influences on women's decision-making, resource challenges and trial process practicalities.
conclusionsSome women are willing to participate in a randomised placebo-controlled trial of corticosteroids prior to a planned caesarean section birth at late preterm and term gestations. Participation in such a trial can be enhanced.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.