P10 Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review
| العنوان: | P10 Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review |
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| المؤلفون: | B Aurich, T Martin-Montoya, D Zhang, E Jacqz-Aigrain |
| المصدر: | Archives of Disease in Childhood. 104:e21.1-e21 |
| بيانات النشر: | BMJ, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Pediatrics, Perinatology and Child Health |
| الوصف: | BackgroundAccording to international guidelines clinical trials are conducted during pregnancy to evaluate benefits and risks of medicines for both the mother and her offspring. Consolidated Standards of Reporting Trials (CONSORT) reporting criteria apply to these trials and should include safety data on the offspring. The safety of maternal treatments is a key issue for health care professionals and parents. Diabetes, human immunodeficiency virus (HIV) infection and hypertension are among the most frequent chronic diseases worldwide in women of child bearing potential. The objective of this systematic review was to analyse offspring data reported in clinical trials conducted in pregnant women receiving chronic drug treatment for one of these conditions.MethodsPubmed and Embase (01/01/1997–31/12/2017) 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 chronic medication and full text in English. Trial characteristics, maternal and offspring data were extracted. Data was summarised by disease and study. Twelve key items were considered for the offspring. The protocol was registered on PROSPERO (CRD42017057024).ResultsOverall, 196 articles reporting 132 clinical trials (diabetes n=55; HIV n=59; hypertension n=18) were included. The number of births were frequently not reported (diabetes 40%; HIV 24%; hypertension 56%). Congenital malformations were infrequently reported with sufficient detail (diabetes 27%; HIV 34%; hypertension 6%). Similar observations were made for other key items (e.g. foetal losses, neonatal deaths, birth weight corrected for gestational age).ConclusionsUnderreporting 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.Disclosure(s)Nothing to disclose |
| تدمد: | 1468-2044 0003-9888 |
| DOI: | 10.1136/archdischild-2019-esdppp.49 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::2d3b9eab2230a7ac6fb07807bbe51273 https://doi.org/10.1136/archdischild-2019-esdppp.49 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi...........2d3b9eab2230a7ac6fb07807bbe51273 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14682044 00039888 |
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| DOI: | 10.1136/archdischild-2019-esdppp.49 |