Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK.
Department of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
BMC Pregnancy Childbirth. 2021 Apr 21;21(1):317. doi: 10.1186/s12884-021-03796-4.
Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management. The CRADLE vital signs alert device accurately measures blood pressure and heart rate, calculates the shock index (heart rate divided by systolic blood pressure) and alerts the user to compromise through a traffic light system reflecting previously validated shock index thresholds.
This is a planned secondary analysis of data from the CRADLE-3 trial from ten clusters across Africa, India and Haiti where the device and training package were randomly introduced. Referral data were prospectively collected for a 4-week period before, and a 4-week period 3 months after implementation. Referrals from primary or secondary care facilities to higher level care for any cause were recorded. The denominator was the number of women seen for maternity care in these facilities.
Between April 1 2016 and Nov 30th, 2017 536,223 women attended maternity care facilities. Overall, 3.7% (n = 2784/74,828) of women seen in peripheral maternity facilities were referred to higher level care in the control period compared to 4.4% (n = 3212/73,371) in the intervention period (OR 0.89; 0.39-2.05) (data for nine sites that were able to collect denominator). Of these 0.29% (n = 212) pre-intervention and 0.16% (n = 120) post-intervention were referred to higher-level facilities for maternal haemorrhage. Although overall referrals did not significantly reduce there was a significant reduction in referrals for obstetric haemorrhage (OR 0.56 (0.39-0.65) following introduction of the device with homogeneity (i-squared 26.1) between sites. There was no increase in any bleeding-related morbidity (maternal death or emergency hysterectomy).
Referrals for obstetric haemorrhage reduced following implementation of the CRADLE Vital Signs Alert Device, occurring without an increase in maternal death or emergency hysterectomy. This demonstrates the potential benefit of shock index in management pathways for obstetric haemorrhage and targeting limited resources in low- middle- income settings.
This study is registered with the ISRCTN registry, number ISRCTN41244132 (02/02/2016).
产科出血是全球孕产妇死亡的主要原因，其中 99%发生在中低收入国家。大多数死亡和不良事件与识别功能障碍和升级护理的延迟有关。严重功能障碍孕妇的处理可能需要转至三级中心进行专科治疗，因此早期识别对于有效处理至关重要。CRADLE 生命体征警报装置可准确测量血压和心率，计算休克指数（心率除以收缩压），并通过反映先前验证的休克指数阈值的红绿灯系统向用户发出功能障碍警报。
这是对非洲、印度和海地 10 个集群的 CRADLE-3 试验数据的计划二次分析，该试验中随机引入了该装置和培训包。在实施前的 4 周和实施后 3 个月的 4 周期间，前瞻性地收集了转诊数据。记录了因任何原因从初级或二级保健机构转至更高一级保健机构的转诊情况。分母为这些设施中接受孕产妇保健的妇女人数。
2016 年 4 月 1 日至 2017 年 11 月 30 日期间，536223 名妇女接受了产妇保健设施的护理。总体而言，与对照组（n=2784/74828，3.7%）相比，干预组（n=3212/73371，4.4%）中，接受基层产妇保健设施护理的妇女中，有 3.7%（n=2784/74828）被转诊至更高一级的保健机构（OR 0.89；0.39-2.05）（来自 9 个能够收集分母的地点的数据）。其中，干预前有 0.29%（n=212），干预后有 0.16%（n=120）转诊至更高一级的设施治疗产科出血。尽管总体转诊率没有显著降低，但转诊治疗产科出血的比例显著降低（装置引入后 OR 0.56（0.39-0.65），组间同质性（I² 为 26.1）。任何出血相关发病率（产妇死亡或紧急子宫切除术）均无增加。
在引入 CRADLE 生命体征警报装置后，产科出血的转诊率下降，且产妇死亡或紧急子宫切除术没有增加。这表明休克指数在产科出血管理路径中具有潜在益处，并针对中低收入环境中的有限资源进行了靶向治疗。
本研究在 ISRCTN 注册处注册，编号 ISRCTN41244132（2016 年 2 月 2 日）。
