Background 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.
Objective 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.
Methods 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.
Results 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).
Conclusion 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.
Trial registration number CRD42017057024.
- qualitative research
- clinical trial
- congenital abnormalities
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Contributors BA and EJA contributed to the conception and design of the work. TMM and DZ were in charge of acquisition of the data. BA and EJA performed the analysis and interpretation of data with the participation of TMM and DZ. BA drafted the first version of the work. EJA revised it. BA, TMM, DZ and EJA approved the final revised version and agreed to be accountable for all aspects of the work.
Funding Partial funding from the FP7-Health programme Global Research in Paediatrics (GRIP) grant agreement number: 261060.
Disclaimer No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests BA has worked for GlaxoSmithKline (GSK) between October 2006 and September 2009 and holds GSK shares. Between October 2009 and May 2015 she has worked for Novartis.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.