ArticleMedical devices (Auckland, N.Z.)2018
Development and usability of a new subcutaneous auto-injector device to administer hydroxyprogesterone caproate to reduce the risk of recurrent preterm birth.
Article in Medical devices (Auckland, N.Z.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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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.
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Who cites it
8 citing papers in PubMed, 13 citations in OpenAlex.
- A phase I clinical study to evaluate rapid, high-volume, subcutaneous auto-injector tolerability with recombinant human hyaluronidase.Drug delivery and translational research · 2026Article
- Seeking a common human factors language for the development and testing of injection devices.Drug delivery · 2025Article
- Vaginal administration of 17-alpha hydroxyprogesterone caproate appears to be safe in non-pregnant female rats and rabbits.Xenobiotica; the fate of foreign compounds in biological systems · 2024Article
- Next generation strategies for preventing preterm birth.Advanced drug delivery reviews · 2021Review
- Self-injectable extended release formulation of Remdesivir (SelfExRem): A potential formulation alternative for COVID-19 treatment.International journal of pharmaceutics · 2021Article
- Applying a Human-Centered Design to Develop a Patient Prioritization Tool for a Pediatric Emergency Department: Detailed Case Study of First Iterations.JMIR human factors · 2020Article
- 17-α Hydroxyprogesterone Nanoemulsifying Preconcentrate-Loaded Vaginal Tablet: A Novel Non-Invasive Approach for the Prevention of Preterm Birth.Pharmaceutics · 2019Article
- A Comparative Analysis of Outcomes Between Two Different Intramuscular Progesterone Preparations in Women Undergoing Frozen Embryo Transfer Cycles.Journal of reproduction & infertilityArticle
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCurrent administration of hydroxyprogesterone caproate (HPC) by intramuscular injection is associated with limitations, including the potential for human error and contamination, patient anxiety, and increased risk of needlestick injury.
objectiveTo describe the design of an auto-injector for subcutaneous (SC) administration of HPC and the results of studies that evaluated the target user's understanding of the proper use of this device. MATERIALS AND
methodsA single-use, prefilled, fixed-dose, disposable auto-injector intended for the SC administration of HPC was developed, and its usability by health care providers was evaluated in 3 formative (N=32, 64 injections) and 3 validation studies (N=45, 90 injections). These studies consisted of one-on-one testing sessions performed in a simulated home environment. Analyses were based on observed use error or use difficulty during the performance of specific tasks, including those considered critical (associated with high severity harms).
resultsIn the formative studies, the majority of participants correctly administered an injection with the auto-injector, but prior training improved performance. Specific errors were noted, including holding the device at the injection site for a period inconsistent with its instructions for use (IFU). The IFU was modified to reduce potential occurrence of these errors. Use errors were subsequently observed on critical tasks in the first and second validation studies, including hold-time errors that were attributed to using visual cues rather than counting seconds. For the third validation study, the IFU was modified to focus on visual cues and all users were able to successfully perform the injection per the IFU.
conclusionAn auto-injector device for SC administration of HPC for reduction in risk of recurrent preterm birth was successfully developed through iterative design and validation testing. The device design provides high usability and acceptance of this device by health care professionals.
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