Hypertensive disorders of pregnancy: Case definitions & guidelines for data collection, analysis, and presentation of immunization safety data

Vaccine

Volumn 34, Issue 49, 2016, Pages 6069-6076

  Rouse, Caroline E ^a   Eckert, Linda O ^b   Wylie, Blair J ^c   Lyell, Deirdre J ^d   Jeyabalan, Arundhathi ^e   Kochhar, Sonali ^f   McElrath, Thomas F ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c MASSACHUSETTS GENERAL HOSPITAL   (United States)

^d STANFORD UNIVERSITY   (United States)

^e UNIVERSITY OF PITTSBURGH   (United States)

^f Global Healthcare Consulting

Author keywords

Adverse event; Case definition; Guidelines; Hypertension in pregnancy; Immunization; Preeclampsia

Indexed keywords

VACCINE;

ADVERSE OUTCOME; ARTICLE; CLASSIFICATION; DATA ANALYSIS; DIAGNOSTIC VALUE; DIFFERENTIAL DIAGNOSIS; HELLP SYNDROME; HUMAN; HYPERTENSION; IMMUNIZATION; INFORMATION PROCESSING; MATERNAL HYPERTENSION; PRACTICE GUIDELINE; PREECLAMPSIA; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; DRUG SURVEILLANCE PROGRAM; FEMALE; PATHOPHYSIOLOGY; PREGNANCY; PREGNANCY COMPLICATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATA COLLECTION; FEMALE; GUIDELINES AS TOPIC; HUMANS; HYPERTENSION; IMMUNIZATION; PREGNANCY; PREGNANCY COMPLICATIONS, CARDIOVASCULAR; VACCINES;

EID: 84999886579     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2016.03.038     Document Type: Article

References (31)

1. [1] Duley, L., The global impact of pre-eclampsia and eclampsia. Semin Perinatol 33 (2009), 130–137.
2. [2] Steegers, E.A., von Dadelszen, P., Duvekot, J.J., Pijnenborg, R., Pre-eclampsia. Lancet 376 (2010), 631–644.
3. [3] LaMarca, B.D., Gilbert, J., Granger, J.P., Recent progress toward the understanding of the pathophysiology of hypertension during preeclampsia. Hypertension 51 (2008), 982–988.
4. [4] Gilbert, J.S., Ryan, M.J., LaMarca, B.B., Sedeek, M., Murphy, S.R., Granger, J.P., Pathophysiology of hypertension during preeclampsia: linking placental ischemia with endothelial dysfunction. Am J Physiol Heart Circ Physiol 294 (2008), H541–H550.
5. [5] Kohl, K.S., Gidudu, J., Bonhoeffer, J., Braun, M.M., Buettcher, M., Chen, R.T., et al. The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine 25 (2007), 5671–5674.
6. [6] Coenders, A., Koopmans, N.K., Broekhuijsen, K., Groen, H., Karstenberg-Kramer, J.M., van Goor, K., et al. Adjuvanted vaccines in pregnancy: no evidence for effect of the adjuvanted H1N1/09 vaccination on occurrence of preeclampsia or intra-uterine growth restriction. Eur J Obstet Gynecol Reprod Biol 187 (2015), 14–19.
7. [7] Millar, M.R., Sanz, M.G., The administration of pertussis vaccine to pregnant women was associated with a small increased risk of chorioamnionitis, but not an increased risk of hypertensive disorders or preterm birth. Evid Based Med, 20, 2015, 73.
8. [8] Kharbanda, E.O., Vazquez-Benitez, G., Lipkind, H., Naleway, A., Lee, G., Nordin, J.D., Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events. Obstet Gynecol 122 (2013), 659–667.
9. [9] Conlin, A.M., Bukowinski, A.T., Sevick, C.J., DeScisciolo, C., Crum-Cianflone, N.F., Safety of the pandemic H1N1 influenza vaccine among pregnant U.S. military women and their newborns. Obstet Gynecol 121 (2013), 511–518.
10. [10] Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy. Obstet Gynecol 122 (2013), 1122–1131.
11. [11] Lisonkova, S., Joseph, K.S., Incidence of preeclampsia: risk factors and outcomes associated with early- versus late-onset disease. Am J Obstet Gynecol, 209, 2013 544 e1–e12.
12. [12] Sikorski, J., Wilson, J., Clement, S., The changing pattern of eclampsia over a 60-year period. Br J Obstet Gynaecol, 105, 1998, 473.
13. [13] Berhan, Y., Berhan, A., Should magnesium sulfate be administered to women with mild pre-eclampsia? A systematic review of published reports on eclampsia. J Obstet Gynaecol Res 41 (2015), 831–842.
14. [14] Hypertension in pregnancy: the management of hypertensive disorders during pregnancy. 2010, Royal College of Obstetricians and Gynaecologists, London.
15. [15] Lowe, S.A., Brown, M.A., Dekker, G.A., Gatt, S., McLintock, C.K., McMahon, L.P., et al. Guidelines for the management of hypertensive disorders of pregnancy 2008. Aust N Z J Obstet Gynaecol 49 (2009), 242–246.
16. [16] Magee, L.A., Pels, A., Helewa, M., Rey, E., von Dadelszen, P., Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy: executive summary. J Obstet Gynaecol Can 36 (2014), 575–576.
17. [17] Brown, M.A., Buddle, M.L., Inadequacy of dipstick proteinuria in hypertensive pregnancy. Aust N Z J Obstet Gynaecol 35 (1995), 366–369.
18. [18] Saudan, P.J., Brown, M.A., Farrell, T., Shaw, L., Improved methods of assessing proteinuria in hypertensive pregnancy. Br J Obstet Gynaecol 104 (1997), 1159–1164.
19. [19] von Dadelszen, P., Payne, B., Li, J., Ansermino, J.M., Broughton Pipkin, F., Cote, A.M., et al. Prediction of adverse maternal outcomes in pre-eclampsia: development and validation of the fullPIERS model. Lancet 377 (2011), 219–227.
20. [20] Roos, N.M., Wiegman, M.J., Jansonius, N.M., Zeeman, G.G., Visual disturbances in (pre)eclampsia. Obstet Gynecol Surv 67 (2012), 242–250.
21. [21] Cooray, S.D., Edmonds, S.M., Tong, S., Samarasekera, S.P., Whitehead, C.L., Characterization of symptoms immediately preceding eclampsia. Obstet Gynecol 118 (2011), 995–999.
22. [22] Sibai, B.M., Diagnosis, controversies, and management of the syndrome of hemolysis, elevated liver enzymes, and low platelet count. Obstet Gynecol 103 (2004), 981–991.
23. [23] Martin, J.N. Jr., Rinehart, B.K., May, W.L., Magann, E.F., Terrone, D.A., Blake, P.G., The spectrum of severe preeclampsia: comparative analysis by HELLP (hemolysis, elevated liver enzyme levels, and low platelet count) syndrome classification. Am J Obstet Gynecol 180 (1999), 1373–1384.
24. [24] Sibai, B.M., Chronic hypertension in pregnancy. Obstet Gynecol 100 (2002), 369–377.
25. [25] Gabbe, S.G., Niebyl, J.R., Simpson, J.L., Obstetrics: normal and problem pregnancies. 2007, Churchill Livingstone/Elsevier, Philadelphia, PA.
26. [26] Sibai, B.M., Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol 206 (2012), 470–475.
27. [27] International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. http://www.ich.org/home.html [accessed 11.12.15].
28. [28] Council for International Organizations of Medical Sciences. http://www.cioms.ch/ [accessed 12.12.15].
29. [29] Moher, D., Schulz, K.F., Altman, D., Group, C., The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285:15 (2001), 1987–1991.
30. [30] Moher, D., Cook, D.J., Eastwood, S., Olkin, I., Rennie, D., Stroup, D.F., Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 354:9193 (1999), 1896–1900.
31. [31] Stroup, D.F., Berlin, J.A., Morton, S.C., Olkin, I., Williamson, G.D., Rennie, D., et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 283:15 (2000), 2008–2012.