Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany.
Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin.
Front Public Health. 2020 Aug 12;8:350. doi: 10.3389/fpubh.2020.00350. eCollection 2020.
Estimating the beginning of pregnancy is crucial when studying drug safety in pregnancy, but important information in this regard, such as the last menstrual period (LMP), is generally not recorded in claims databases. The beginning of pregnancy is therefore usually estimated by subtracting a median length of pregnancy from the date of birth. Due to the variability in pregnancy lengths, this might result in non-negligible errors. German claims data may offer the possibility to estimate the beginning of pregnancy more precisely based on the expected delivery date (EDD) which can be coded once or more often during a pregnancy. To estimate the beginning of pregnancy in German claims data focusing on the potential of the expected delivery date (EDD). We included data of all pregnancies in women aged 12-50 years ending in a live birth between 2006 and 2015 identified in the German Pharmacoepidemiological Research Database (GePaRD). We assessed the number of coded EDDs per pregnancy and the concordance if ≥ 2 EDDs were coded. We estimated the beginning of pregnancy by subtracting 280 days from the EDD or the most frequent EDD (in case of discordant EDDs). To examine plausibility, we determined the distribution of pregnancy lengths and assessed whether the gestational age at which prenatal examinations were coded was plausible. For pregnancies without EDD, the beginning was estimated by subtracting the respective observed median lengths of pregnancy for preterm births, term births, and births after due date from the actual dates of birth. In 82.4% of pregnancies, at least one EDD was available (thereof 6.1% with only one EDD and 80.9% with ≥ 2 EDDs that were all concordant). The maximal difference between discordant EDDs was in median 5 days (interquartile range: 3-7 days). Based on the EDD, the median length of pregnancy was 276 days for term births and in 84.7% of pregnancies the second antibody screening test was performed in the recommended interval ± 2 weeks. In pregnancies without EDD the respective proportion was 84.9%. By using the EDD, the beginning of pregnancy can plausibly be estimated in German claims data.
估算妊娠开始时间对于研究妊娠期间药物安全性至关重要,但此类重要信息(如末次月经)通常未记录在理赔数据库中。因此,妊娠开始时间通常通过从出生日期中减去妊娠中位数长度来估算。由于妊娠长度存在差异,这可能会导致不可忽视的误差。德国理赔数据可能提供了一种更精确估算妊娠开始时间的可能性,其基于可在妊娠期间编码一次或多次的预计分娩日期(EDD)。
基于预计分娩日期(EDD),在德国理赔数据中估算妊娠开始时间,以评估 EDD 的潜力。
我们纳入了 2006 年至 2015 年期间在德国 Pharmacoepidemiological Research Database(GePaRD)中记录的年龄在 12-50 岁之间、分娩结局为活产的所有妊娠女性的数据。我们评估了每次妊娠编码 EDD 的数量以及编码≥2 次 EDD 的一致性。我们通过从 EDD 或最常见的 EDD 中减去 280 天来估算妊娠开始时间(在 EDD 不一致的情况下)。为了检验合理性,我们确定了妊娠长度的分布,并评估了编码产前检查时的胎龄是否合理。对于没有 EDD 的妊娠,通过从实际出生日期中减去早产、足月和过期妊娠的相应观察到的中位数妊娠长度来估算开始时间。
82.4%的妊娠至少有一个 EDD(其中 6.1%只有一个 EDD,80.9%有≥2 个 EDD,且所有 EDD 均一致)。不一致 EDD 之间的最大差异中位数为 5 天(四分位距:3-7 天)。基于 EDD,足月分娩的中位妊娠长度为 276 天,在 84.7%的妊娠中,第二次抗体筛查试验在推荐的±2 周间隔内进行。在没有 EDD 的妊娠中,相应的比例为 84.9%。
通过使用 EDD,可在德国理赔数据中合理估算妊娠开始时间。