Sanchez Ortiz Sara, Huerta Consuelo, Llorente-García Ana, Ortega Paloma, Astasio Paloma, Cea-Soriano Lucía
Department of Preventive Medicine and Public Health, Faculty of Medicine, Complutense University of Madrid, 28040 Madrid, Spain.
BIFAP, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices (AEMPS), 28040 Madrid, Spain.
Healthcare (Basel). 2021 May 18;9(5):596. doi: 10.3390/healthcare9050596.
(1) Background: There is a major gap of knowledge towards the natural history of miscarriages in electronic medical records. We aimed to calculate the frequency of miscarriages using data from BIFAP database. (2) Methods: We identified all pregnancy losses and carried out a multistep validation exercise. Potential cases with positive predictive values (PPV) of miscarriage confirmation <85% or those confirming other pregnancy loss were excluded. Kaplan-Meier figures and incidence rates (IRs) of miscarriage with 95% confidence intervals (CIs) expressed by 1000 person-weeks were calculated. Stratifying analysis by age, specific high-risk groups, and drug exposure within the pre-pregnancy period were performed restricted to women with recording last menstrual period (LMP). (3) Results: Women with confirmed miscarriage ( = 18,070), tended to be older, with higher frequency of comorbidities and drug utilization. Restricting to women with LPM recorded, IR of miscarriage was 10.89 (CI 95% 10.68-11.10) per 1000 women-weeks, with a median follow-up of 10 weeks (IQR: 8-12). The IR according to age was: 2.71 (CI 95% 2.59-2.84) in those aged <30 years compared to 9.11 (CI 95% 8.55-9.70) in women aged ≥40 years. Advanced maternal age (Hazard Ratio (HR, 95% confidence interval) CI 95%: 3.34 (3.08-3.62)), use of antihypertensives (1.49 (1.21-1.84), and use of drugs classified as D or X during pregnancy (1.17 (1.07-1.29)) showed to be positive predictors associated with increased risk of miscarriages. (4) Conclusion: BIFAP database can be used to identify women suffering from miscarriages, which will serve to further study risk factors associated with miscarriages with special attention to drug utilization.
(1) 背景：电子病历中对于流产自然史的认识存在重大知识空白。我们旨在利用BIFAP数据库的数据计算流产发生率。(2) 方法：我们识别出所有妊娠丢失情况，并进行了多步骤验证。排除流产确认阳性预测值（PPV）<85%的潜在病例或确认其他妊娠丢失的病例。计算了Kaplan-Meier图以及每1000人周的流产发生率（IR）及95%置信区间（CI）。仅对记录了末次月经（LMP）的女性按年龄、特定高危组以及孕前药物暴露情况进行分层分析。(3) 结果：确诊流产的女性（n = 18,070）往往年龄较大，合并症和药物使用频率较高。仅纳入记录了LPM的女性，每1000女性周的流产发生率为10.89（95%CI 10.68 - 11.10），中位随访时间为10周（四分位间距：8 - 12周）。按年龄划分的发生率为：<30岁者为2.71（95%CI 2.59 - 2.84），≥40岁女性为9.11（95%CI 8.55 - 9.70）。高龄产妇（风险比（HR，95%置信区间）CI 95%：3.34（3.08 - 3.62））、使用抗高血压药物（1.49（1.21 - 1.84））以及孕期使用D类或X类药物（1.17（1.07 - 1.29））显示为与流产风险增加相关的阳性预测因素。(4) 结论：BIFAP数据库可用于识别流产女性，这将有助于进一步研究与流产相关的风险因素，尤其关注药物使用情况。
