Medical Faculty, Christian-Albrechts-Universität Kiel, Christian-Albrechts-Platz 4, 24118, Kiel, Germany.
Department of Gynecology and Obstetrics, Charité - Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Arch Gynecol Obstet. 2023 Sep;308(3):831-838. doi: 10.1007/s00404-022-06754-3. Epub 2022 Aug 28.
Intrahepatic cholestasis of pregnancy (ICP) is associated with adverse fetal and neonatal outcome. Evidence for improvement by obstetric management is sparse. Common international guidelines recommend induction of labor before term, however, they differ in recommendations of monitoring the disease and time point of active management. So far, an official guideline for treatment and management of ICP in Germany does not exist. This study aims to compile common practice and policy in obstetric management of ICP in German maternity units. The objective is to gather obstetricians' opinion on management of ICP, and to estimate the need for standardization of current practice in Germany on the background of existing evidence.
A questionnaire focusing on indications for interventions was developed including fourteen multiple-choice questions comprising the areas of diagnostic criteria, laboratory testing, fetal monitoring, treatment, and delivery timing. The survey was sent to 699 maternity clinics and was distributed to participants of the annual congress hosted by the German society of perinatal medicine (DGPM). Collected data were summarized and evaluated in relation to available evidence and existing guidelines. Descriptive statistics and Fisher's exact test were used.
334 completed questionnaires returned corresponding to a response rate of 48.1%. Coinciding with existing international guidelines, 48.8% of the participants acknowledge bile acid concentrations above 10 µmol/L to be indicative of ICP. 85.0% of obstetricians recommend antenatal testing with cardiotocography, exceeding common standards of maternity policy guidelines; 50.3% execute active management in ICP-affected pregnancies as they generally recommend a delivery between 37 + 0 and 38 + 6 weeks of gestation. Although recent studies evinced a risk of stillbirth in ICP-affected pregnancies not until a bile acid concentration of > 100 µmol/L, 22.2% of the respondents recommend delivery before 37 + 0 weeks of gestation due to raised bile acids of 40-99 µmol/L.
Opinions on the management of ICP in German maternity units differ widely and partly deviate by large from international standards. Reasons for this may be the lack of a national guideline and the low awareness due to the rarity of the disease on the one hand and the very slow dynamics in evidence generation and thus the uncertainty about the actual risks and optimal management on the other. The present data highlight the need for further research and clinical guidelines to standardize and optimize treatment based on the best available evidence.
妊娠肝内胆汁淤积症（ICP）与不良的胎儿和新生儿结局相关。尽管产科管理可能会改善结局，但目前仅有少量证据支持这种做法。国际上的常见指南建议在足月前引产，但在监测疾病和积极管理的时间点方面，它们的建议存在差异。到目前为止，德国还没有针对 ICP 治疗和管理的官方指南。本研究旨在总结德国产科单位中 ICP 产科管理的常见实践和政策。目的是收集产科医生对 ICP 管理的意见，并根据现有证据评估当前实践标准化的必要性。
我们制定了一份重点关注干预措施适应证的问卷，其中包含 14 个多项选择题，涵盖诊断标准、实验室检查、胎儿监测、治疗和分娩时机等领域。该调查已发送至 699 家产科诊所，并分发给德国围产医学学会（DGPM）年会的参与者。收集的数据与现有证据和指南进行了总结和评估。采用描述性统计和 Fisher 精确检验进行分析。
334 份完成的问卷回复，对应 48.1%的应答率。与现有的国际指南一致，48.8%的参与者认为胆汁酸浓度>10µmol/L 提示 ICP。85.0%的产科医生建议进行产前胎心监护检查，这超过了产科政策指南的常见标准；50.3%的产科医生对 ICP 孕妇进行积极管理，因为他们普遍建议在 37+0 至 38+6 孕周之间分娩。尽管最近的研究表明，胆汁酸浓度>100µmol/L 才会增加 ICP 孕妇的死产风险，但仍有 22.2%的受访者建议在 37+0 孕周之前分娩，因为胆汁酸浓度在 40-99µmol/L 时就会升高。
德国产科单位对 ICP 管理的意见存在很大差异，部分意见与国际标准相差甚远。其原因一方面可能是缺乏国家指南，另一方面也可能是由于该病罕见，导致对其认识不足，同时证据生成速度非常缓慢，因此对实际风险和最佳管理存在不确定性。目前的数据突出了进一步研究和临床指南的必要性，以根据现有最佳证据对治疗进行标准化和优化。
