背景:2016年在肯尼亚引入了孕产妇和围产期死亡监测和反应(MPDSR),三年后于2019年在Kiambu5级医院(KL5H)实施。在KL5H的例行MPDSR会议上,委员会成员确定了在标签外使用200mcg米索前列醇片剂八次以达到引产所需剂量(25mcg)和孕产妇死亡之间可能存在联系。在此之后,2019年6月,行政决定将米索前列醇转为地诺前列酮引产.本研究旨在评估MPDSR的总体影响以及用地诺前列酮替代米索前列醇对子宫破裂的影响。KL5H的孕产妇和新生儿死亡。
方法:我们对2018年1月至2020年12月在KL5H分娩的妇女进行了一项回顾性队列研究。我们将干预前期定义为2018年1月-2019年6月,干预期为2019年7月-2020年12月。我们随机抽取了411位母亲的记录,167来自干预前时期,208来自干预期,他们都是被诱导的。我们使用贝叶斯-泊松广义线性模型来拟合子宫破裂的风险,孕产妇和围产期死亡。使用了12份半结构化的关键人物问卷来描述员工对从米索前列醇转向地诺前列酮的看法。进行了归纳和演绎数据分析,以捕获突出的新兴主题。
结果:我们回顾了411例患者的记录,并进行了12次重要的线人访谈。用米索前列醇诱导的母亲(IRR=3.89;CI=0.21-71.6)死亡风险增加,而用地诺前列酮诱导的母亲(IRR=0.23;CI=0.01-7.12)或子宫破裂(IRR=0.56;CI=0.02-18.2)死亡的可能性较小。当MPDSR活动加强时,在2019年7月至2020年12月期间,生育期间死亡的风险增加(IRR=5.43,CI=0.68-43.2)。在我们的环境中,引产(IRR=1.01;CI=0.06-17.1)对死于分娩的风险没有影响。定性结果表明,产科工作人员更喜欢地诺前列酮而不是米索前列醇,因为它被认为更有效(失败的诱导次数更少)并且更安全,与米索前列醇相比更昂贵。
结论:虽然在KL5H实施MPDSR后的这段时间与死亡风险增加有关,转用地诺前列酮引产与产妇和围产期死亡风险较低相关.使用地诺前列酮,然而,与子宫破裂的风险增加有关,这可能归因于劳工监督减少,因为工作人员认为它本质上比米索前列醇更安全。因此,即使转换是有必要的,需要进一步调查以确定孕产妇死亡率上升的原因,尽管MPDSR框架似乎已经到位,以平息这种增长。
BACKGROUND: The Maternal and Perinatal Death Surveillance and Response (MPDSR) was introduced in Kenya in 2016 and implemented at Kiambu Level 5 Hospital (KL5H) three years later in 2019. During a routine MPDSR meeting at KL5H, committee members identified a possible link between the off-label use of 200mcg misoprostol tablets divided eight times to achieve the necessary dose for labour induction (25mcg) and maternal deaths. Following this, an administrative decision was made to switch from misoprostol to dinoprostone for the induction of labour in June of 2019. This study aimed to assess the overall impact of MPDSR as well as the effect of replacing misoprostol with dinoprostone on uterine rupture, maternal and neonatal deaths at KL5H.
METHODS: We conducted a retrospective cohort study of women who gave birth at KL5H between January 2018 and December 2020. We defined the pre-intervention period as January 2018-June 2019, and the intervention period as July 2019-December 2020. We randomly selected the records of 411 mothers, 167 from the pre-intervention period and 208 from the intervention period, all of whom were induced. We used Bayes-Poisson Generalised Linear Models to fit the risk of uterine rupture, maternal and perinatal death. 12 semi-structured key person questionnaires was used to describe staff perspectives regarding the switch from misoprostol to dinoprostone. Inductive and deductive data analysis was done to capture the salient emerging themes.
RESULTS: We reviewed 411 patient records and carried out 12 key informant interviews. Mothers induced with misoprostol (IRR = 3.89; CI = 0.21-71.6) had an increased risk of death while mothers were less likely to die if they were induced with dinoprostone (IRR = 0.23; CI = 0.01-7.12) or had uterine rupture (IRR = 0.56; CI = 0.02-18.2). The risk of dying during childbearing increased during Jul 2019-Dec 2020 (IRR = 5.43, CI = 0.68-43.2) when the MPDSR activities were strengthened. Induction of labour (IRR = 1.01; CI = 0.06-17.1) had no effect on the risk of dying from childbirth in our setting. The qualitative results exposed that maternity unit staff preferred dinoprostone to misoprostol as it was thought to be more effective (fewer failed inductions) and safer, regardless of being more expensive compared to misoprostol.
CONCLUSIONS: While the period immediately following the implementation of MPDSR at KL5H was associated with an increased risk of death, the switch to dinoprostone for labour induction was associated with a lower risk of maternal and perinatal death. The use of dinoprostone, however, was linked to an increased risk of uterine rupture, possibly attributed to reduced labour monitoring given that staff held the belief that it is inherently safer than misoprostol. Consequently, even though the changeover was warranted, further investigation is needed to determine the reasons behind the rise in maternal mortalities, even though the MPDSR framework appeared to have been put in place to quell such an increase.