ArticleBMC medical research methodology2013
Is a randomised controlled trial of a maternity care intervention for pregnant adolescents possible? An Australian feasibility study.
Article in BMC medical research methodology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
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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
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- Midwife continuity of care models versus other models of care for childbearing women.The Cochrane database of systematic reviews · 2024Pooled it
- Midwife-led continuity models versus other models of care for childbearing women.The Cochrane database of systematic reviews · 2016Pooled it
- What can we learn from a failed trial: insight into non-participation in a chat-based intervention trial for adolescents with psychosocial problems.BMC research notes · 2014Trial
- Treatment preference and recruitment to pediatric RCTs: A systematic review.Contemporary clinical trials communications · 2019Article
- Article
- Is model of care associated with infant birth outcomes among vulnerable women? A scoping review of midwifery-led versus physician-led care.SSM - population health · 2016Article
- Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.PloS one · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe way in which maternity care is provided affects perinatal outcomes for pregnant adolescents; including the likelihood of preterm birth. The study purpose was to assess the feasibility of recruiting pregnant adolescents into a randomised controlled trial, in order to inform the design of an adequately powered trial which could test the effect of caseload midwifery on preterm birth for pregnant adolescents.
methodsWe recruited pregnant adolescents into a feasibility study of a prospective, un-blinded, two-arm, randomised controlled trial of caseload midwifery compared to standard care. We recorded and analysed recruitment data in order to provide estimates to be used in the design of a larger study.
resultsThe proportion of women aged 15-17 years who were eligible for the study was 34% (n=10), however the proportion who agreed to be randomised was only 11% (n = 1). Barriers to recruitment were restrictive eligibility criteria, unwillingness of hospital staff to assist with recruitment, and unwillingness of pregnant adolescents to have their choice of maternity carer removed through randomisation.
conclusionsA randomised controlled trial of caseload midwifery care for pregnant adolescents would not be feasible in this setting without modifications to the research protocol. The recruitment plan should maximise opportunities for participation by increasing the upper age limit and enabling women to be recruited at a later gestation. Strategies to engage the support of hospital-employed staff are essential and would require substantial, and ongoing, work. A Zelen method of post-randomisation consent, monetary incentives and 'peer recruiters' could also be considered.
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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.