Division of Women's Health, Faculty of Life Sciences & Medicine, King's College London, 10th Floor, North Wing, St Thomas's Hospital Campus, London, SE1 7EH, UK.
BMC Pregnancy Childbirth. 2019 Feb 13;19(1):68. doi: 10.1186/s12884-019-2210-1.
Accurate diagnosis of preterm labour is needed to ensure correct management of those most at risk of preterm birth and to prevent the maternal and fetal risks incurred by unnecessary interventions given to the large majority of women, who do not deliver within a week of presentation. Intervention "just-in-case" results in many avoidable admissions, women being transferred out of their local hospital unnecessarily and most women receiving unwarranted drugs, such as steroids and tocolytics. It also precludes appropriate transfers for others as neonatal cots are blocked pre-emptively, resulting in more dangerous ex-utero transfers. We have developed the QUiPP App which is a clinical decision-making aid based on previous outcomes of women, quantitative fetal fibronectin (qfFN) values and cervical length. It is hypothesised that using the QUiPP app will reduce inappropriate admissions and transfers.
A multi-site cluster randomised trial will evaluate whether the QUiPP app reduces inappropriate management for threatened preterm labour. The 13 participating centres will be randomly allocated to receive either intervention or control. If the QUiPP app calculates risk of delivery within 7 days to be is less than 5%, clinicians are advised that interventions may be withheld. Women's experience of threatened preterm labour assessment will be explored using self-completed questionnaires, with a subset of participants being invited to semi-structured interview. A health economics analysis is also planned.
We hypothesise that the QUiPP app will improve identification of the most appropriate women for admission and transfer and ensure that therapies known to reduce risk of preterm neonatal morbidities are offered to those who need them. We will determine which women do not require these therapies, thereby reducing over-medicalisation and the associated maternal and fetal risks for these women. The findings will inform future national guidelines on threatened preterm labour. Beyond obstetrics, evaluating the impact of an app in an emergency setting, and our emphasis on balancing harms of over-treatment as well as under-treatment, make EQUIPTT a valuable contribution to translational medicine.
The EQUIPTT trial was prospectively registered on 16th January 2018 with the ISRCTN registry (no. 17846337 ).
需要准确诊断早产，以确保对那些最有可能早产的孕妇进行正确的管理，并防止对大多数不在一周内分娩的孕妇进行不必要的干预，因为这些干预会带来母婴风险。“以防万一”的干预措施会导致许多不必要的住院治疗，孕妇不必要地转移到他们当地的医院，大多数孕妇接受不必要的药物，如类固醇和保胎药物。它还排除了对其他人的适当转移，因为新生儿床被预先占用，导致更危险的子宫外转移。我们开发了 QUiPP 应用程序，这是一种基于先前孕妇结果、定量胎儿纤维连接蛋白（qfFN）值和宫颈长度的临床决策辅助工具。假设使用 QUiPP 应用程序将减少不适当的住院治疗和转移。
一项多中心集群随机试验将评估 QUiPP 应用程序是否减少了对威胁早产的不适当管理。参与的 13 个中心将被随机分配接受干预或对照组。如果 QUiPP 应用程序计算出在 7 天内分娩的风险小于 5%，则建议临床医生可以不进行干预。将使用自我完成的问卷来探讨女性对威胁早产评估的体验，邀请部分参与者进行半结构化访谈。还计划进行健康经济学分析。
我们假设 QUiPP 应用程序将改善对最合适的住院和转移妇女的识别，并确保将已知可以降低早产新生儿发病率风险的治疗方法提供给那些需要的妇女。我们将确定哪些妇女不需要这些治疗方法，从而减少过度治疗，并降低这些妇女的母婴风险。研究结果将为未来关于威胁早产的国家指南提供信息。除了产科，评估应用程序在紧急情况下的影响，以及我们对平衡过度治疗和治疗不足的危害的重视，使 EQUIPTT 对转化医学做出了宝贵贡献。
EQUIPTT 试验于 2018 年 1 月 16 日前瞻性地在 ISRCTN 登记处（编号 17846337）注册。
