Data Resources for Investigating Drug Exposure during Pregnancy and Associated Outcomes: The General Practice Research Database (GPRD) as an Alternative to Pregnancy Registries

Charlton, Rachel A.; Cunnington, Marianne C.; de Vries, Corinne S.; Weil, John G.
January 2008
Drug Safety;2008, Vol. 31 Issue 1, p39
Academic Journal
Pregnancy registries are the most commonly used data resource for the post-marketing surveillance of drug teratogenicity. However, the limited sample size and potential selection bias in these registries has led us to investigate the potential of the UK General Practice Research Database (GPRD) as an alternative data source for monitoring drug safety during pregnancy. In addition, a literature review identified further observational data sources that monitor pregnancy outcomes for future evaluation. Initial feasibility studies focused on the ability of the GPRD to capture pregnancy outcomes for a range of drug class exposures, all of which are currently under investigation in pregnancy registries, during pregnancy. The comparator pregnancy registries were identified via a MEDLINE search, whilst eligible pregnancies, in which women received one or more prescriptions for the drug of interest during pregnancy, were identified in the GPRD using the mother-baby link. The number of pregnancy outcomes following exposure to medication for a range of conditions with varying prevalence, including depression, migraine, epilepsy, herpes simplex and HIV, captured by the two data sources were compared. For depression, a relatively prevalent condition, the GPRD recorded the same number of mean annual intrauterine exposures to fluoxetine as the pregnancy registry (118 exposures/year). Ascertainment of intrauterine exposure to drug treatments for less prevalent conditions was found to be higher for the pregnancy registries than the GPRD; for the older antiepileptic drugs (valproate and carbamazepine), the pregnancy registry recorded between four and five times as many mean annual exposures as the GPRD. Virtually no antiretroviral exposures (three) were identified during the time period of interest on the GPRD, compared with 3946 in the Antiretroviral Pregnancy Registry. Data from the GPRD meet established criteria for evaluating outcomes of pregnancy. For prevalent conditions, it has the potential to replace or work alongside standard pregnancy registries and the alternative data sources identified. Further studies are now needed to assess its ability to replicate known teratogenic associations.


Related Articles

  • Mood instability during pregnancy and postpartum: a systematic review. Li, Hua; Bowen, Angela; Bowen, Rudy; Balbuena, Lloyd; Feng, Cindy; Bally, Jill; Muhajarine, Nazeem // Archives of Women's Mental Health;Feb2020, Vol. 23 Issue 1, p29 

    Perinatal mood instability (MI) is a common clinical observation in perinatal women, and existing research indicates that MI is strongly associated with a variety of mental disorders. The purpose of this study is to review the evidence of perinatal MI systematically, with a focus on perinatal...

  • Discovering gene annotations in biomedical text databases. Cakmak, Ali; Ozsoyoglu, Gultekin // BMC Bioinformatics;2008, Vol. 9, Special section p1 

    Background: Genes and gene products are frequently annotated with Gene Ontology concepts based on the evidence provided in genomics articles. Manually locating and curating information about a genomic entity from the biomedical literature requires vast amounts of human effort. Hence, there is...

  • A Review Of Common Dental Treatments During Pregnancy: Implications For Patients and Dental Personnel. Wasylko, L.; Matsui, D.; Dykxhoorn, S. M.; Rieder, M. J.; Weinberg, S. // Journal of the Canadian Dental Association;Jun1998, Vol. 64 Issue 6, p434 

    In general, pregnant females tend to over estimate the risk of teratogenicity in the foetus resulting from medical and dental procedures and/or drugs. This may cause them to avoid necessary treatment, leading to detrimental health effects for both the foetus and themselves. In this review, the...

  • Anticonvulsant teratogenicity.  // Caribbean Health;Oct2001, Vol. 4 Issue 5, p32 

    The article focuses on the study on the teratogenicity of anticonvulsant drugs, conducted in Boston, Massachusetts. The study aims to determine the embryonic development of a child during pregnancy, whose mother has history of epilepsy or has taken an anticonvulsant drugs. Based from the study,...

  • A case-control study of congenital abnormality and dimenhydrinate usage during pregnancy. Czeizel, A. E.; Vargha, P. // Archives of Gynecology & Obstetrics;Feb2005, Vol. 271 Issue 2, p113 

    Objective The objective was to determine the teratogenicity of dimenhydrinate, an anti-emetic drug. Methods We compared patients with congenital abnormalities with matched normal controls. Cases were taken from the population-based data set of the Hungarian Case-Control Surveillance of...

  • MEMBRANE STRIPPING TO PROMOTE LABOR. King, Valerie J. // Journal of Family Practice;Aug1996, Vol. 43 Issue 2, p119 

    The article discusses research being done on the effectiveness of membrane stripping at term to promote the onset of labor. It references a study by B. Wiriyasirivaj and colleagues, published in a 1996 issue of "Obstetrics and Gynecology." The non-blinded randomized controlled trial enrolled 256...

  • Colonización materna por Streptococcus del grupo B en México: estimación de la prevalencia basada en la revisión bibliográfica. Reyna Figueroa, Jesús; Javier Ortiz Ibarra, Federico; Esteves Jaramillo, Alejandra; Casanova Román, Gerardo // Ginecologia y Obstetricia de Mexico;jul2007, Vol. 75 Issue 7, p399 

    Objective: To identify the prevalence of colonization of Mexican pregnant women with Group B streptococci, based on a Mexican literature review. Methods. Trials of prevalence for Group B Streptococci colonization in Mexican pregnant women were identified using a MEDLINE, Artemisa, LILACS and...

  • Specific features of the psychoautonomic status of pregnant women with autonomic dysfunction. MASLYANKINA, K. P.; ALEKSANDROV, L. S.; ISHCHENKO, A. I.; TUTTER, N. V.; TRIFONOVA, N. S. // Rossiiskii Vestnik Akushera-Ginekologa;2014, Vol. 14 Issue 3, p11 

    Objective. To study the specific features of the psychoautonomic status in pregnant women with autonomic dysfunction. Subjects and methods. A study group consisted of 104 pregnant women with autonomic dysfunction who had different pregnancy periods: 34 women in the first trimester, 34 in the...

  • Patterns and determinants of care seeking for obstetric complications in rural northwest Bangladesh: analysis from a prospective cohort study. Sikder, Shegufta S.; Labrique, Alain B.; Craig, Ian M.; Wakil, Mohammad Abdul; Shamim, Abu Ahmed; Mehra, Hasmot Sucheta; Wu, Lee; Shaikh, Saijuddin; West Jr, Keith P.; Christian, Parul // BMC Health Services Research;2015, Vol. 15 Issue 1, p1 

    Background: In communities with low rates of institutional delivery, little data exist on care-seeking behavior for potentially life-threatening obstetric complications. In this analysis, we sought to describe care-seeking patterns for self-reported complications and near misses in rural...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics