Pediatric Pharmacology and Pharmacogenetics, Hopital Universitaire Robert Debre, Paris, France.
Pediatric Pharmacology and Pharmacogenetics, Hopital Universitaire Robert Debre, Paris, France
Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):215-221. doi: 10.1136/archdischild-2019-316982. Epub 2019 Oct 9.
Clinical trials are conducted during pregnancy to evaluate benefits and risks of medicines for mother and child. The safety of maternal treatments is a key issue for healthcare professionals and parents.
To analyse offspring data reported in clinical trials in pregnant women with diabetes, HIV infection or hypertension (three of the most common diseases in women of childbearing potential) and either treated prior to pregnancy for these chronic diseases or diagnosed and treated during pregnancy.
PubMed and Embase (1 January 1997 to 31 December 2017) were searched for drug trials in pregnant women with diabetes, HIV infection or hypertension. Titles and abstracts were screened, followed by a full-text review of eligible articles. Inclusion criteria were interventional clinical trials in pregnant women treated with medication and full text in English. Trial characteristics, maternal and offspring data were extracted. Data were summarised by disease and study. Twelve key items were considered for the offspring.
Overall, 196 articles reporting 132 clinical trials (diabetes n=55; HIV n=59; hypertension n=18) were included. Key offspring data were frequently not reported, for example, number of births (diabetes: 22/55, 40%; HIV: 14/59, 24%; hypertension: 10/18, 56%). Congenital malformations were often not reported with sufficient detail (diabetes: 40/55, 73%; HIV: 39/59, 66%; hypertension: 17/18, 94%). Similar observations were made for other key items (eg, fetal losses, neonatal deaths).
Under-reporting of key data for the offspring was frequent in publications of clinical trials in pregnant women with diabetes, HIV infection or hypertension making the assessment of the benefit-risk ratio of treatment options during pregnancy difficult.
CRD42017057024.
为了评估药物对母婴的益处和风险，会在妊娠期间开展临床试验。孕产妇治疗的安全性是医疗保健专业人员和家长关注的关键问题。
分析患有糖尿病、HIV 感染或高血压（生育期女性最常见的三种疾病）的孕妇在妊娠前治疗或妊娠期间确诊和治疗的临床试验中报告的后代数据。
检索 1997 年 1 月 1 日至 2017 年 12 月 31 日期间 PubMed 和 Embase 中关于患有糖尿病、HIV 感染或高血压的孕妇的药物试验，筛选标题和摘要，然后对合格文章进行全文审查。纳入标准为用药物治疗孕妇的干预性临床试验和英文全文。提取试验特征、母婴和后代数据。按疾病和研究进行数据汇总。共考虑了 12 个后代关键项目。
共纳入 196 篇文章，报道了 132 项临床试验（糖尿病 55 项，HIV 59 项，高血压 18 项）。重要的后代数据经常未报告，例如，分娩数量（糖尿病：22/55，40%；HIV：14/59，24%；高血压：10/18，56%）。先天性畸形的报告往往缺乏详细信息（糖尿病：40/55，73%；HIV：39/59，66%；高血压：17/18，94%）。其他关键项目也存在类似的观察结果（例如，胎儿丢失，新生儿死亡）。
患有糖尿病、HIV 感染或高血压的孕妇临床试验报告中，后代的关键数据经常漏报，这使得评估妊娠期间治疗选择的利弊比变得困难。
CRD42017057024。
