Double blind, randomised, placebocontrolled trial to evaluate the efficacy of esomeprazole to treat early onset pre-eclampsia (PIE Trial): A study protocol

BMJ Open

Volumn 5, Issue 10, 2015, Pages

  Cluver, Catherine A ^a,b   Walker, Susan P ^b   Mol, Ben W ^c   Theron, Gerard B ^a   Hall, David R ^a   Hiscock, Richard ^b   Hannan, N ^b   Tong, S ^b  

^a STELLENBOSCH UNIVERSITY   (South Africa)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c UNIVERSITY OF ADELAIDE   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ENDOGLIN; ENDOTHELIN 1; ESOMEPRAZOLE; FMS LIKE TYROSINE KINASE 1; HYPOXIA INDUCIBLE FACTOR 1ALPHA; MESSENGER RNA; PLACEBO; PLACENTAL GROWTH FACTOR; PROSTAGLANDIN F; PROTEIN TYROSINE KINASE; UNCLASSIFIED DRUG; VASCULOTROPIN; PROTON PUMP INHIBITOR;

ARTICLE; BLOOD SAMPLING; BRAIN HEMORRHAGE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; ECLAMPSIA; ENDOTHELIAL DYSFUNCTION; ENDOTHELIUM CELL; FETUS OUTCOME; HUMAN; LIVER HEMATOMA; LUNG DYSPLASIA; LUNG EDEMA; MATERNAL MORTALITY; MAXIMUM PLASMA CONCENTRATION; NECROTIZING ENTEROCOLITIS; OXIDATIVE STRESS; PHASE 2 CLINICAL TRIAL; PLACENTA; PREECLAMPSIA; PREGNANCY OUTCOME; RANDOMIZED CONTROLLED TRIAL; SEVERE RENAL IMPAIRMENT; ADULT; CLINICAL PROTOCOL; FEMALE; GESTATIONAL AGE; METHODOLOGY; NEWBORN; OBSTETRIC DELIVERY; PRE-ECLAMPSIA; PREGNANCY; TREATMENT OUTCOME;

ADULT; CLINICAL PROTOCOLS; DELIVERY, OBSTETRIC; DOUBLE-BLIND METHOD; ESOMEPRAZOLE; FEMALE; GESTATIONAL AGE; HUMANS; INFANT, NEWBORN; PRE-ECLAMPSIA; PREGNANCY; PREGNANCY OUTCOME; PROTON PUMP INHIBITORS; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 84949510750     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-008211     Document Type: Article

References (21)

1. Lain KY, Roberts JM. Contemporary concepts of the pathogenesis and management of preeclampsia. JAMA 2002;287:3183-6.
2. ACOG Committee on Obstetric Practice. Practice bulletin# 33: diagnosis and management of preeclampsia and eclampsia. Obstet Gynecol 2002;99:159-67.
3. Dolea C, AbouZahr C. Global burden of hypertensive disorders of pregnancy in the year 2000. Evidence and information for policy (EIP). Geneva: World Health Organization, 2003.
4. Redman CW, Sargent IL. Latest advances in understanding preeclampsia. Science 2005;308:1592-4.
5. Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet 2005;365:785-99.
6. Sibai BM. Diagnosis and management of gestational hypertension and preeclampsia. Obstet Gynecol 2003;102:181-92.
7. Zhang J, Meikle S, Trumble A. Severe maternal morbidity associated with hypertensive disorders in pregnancy in the United States. Hypertens Pregnancy 2003;22:203-12.
8. United Nations Millenium Development Goals. http://www.un.org/millenniumgoals/(accessed Feb 2015).
9. Levine RJ, Maynard SE, Qian C, et al. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med 2004;350:672-83.
10. Gill SK, O'Brien L, Einarson TR, et al. The safety of proton pump inhibitors (PPIs) in pregnancy: A meta-Analysis. Am J Gastroenterol 2009;104:1541-5.
11. Matok I, Levy A, Wiznitzer A, et al. The safety of fetal exposure to proton-pump inhibitors during pregnancy. Dig Dis Sci 2012;57:699-705.
12. Pasternak B, Hviid A. Use of proton-pump inhibitors in early pregnancy and the risk of birth defects. N Engl J Med 2010;363:2114-23.
13. Onda K, Hannan N, Beard S, et al. Proton Pump inhibitors for treatment of preeclampsia Abstract 6-OR. XIX Word Congress ISSHP; 26-29 Oct 2014.
14. Magee LA, Pels A, Helewa M, et al. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy. Pregnancy Hypertens 2014;4:105-45.
15. Hall DR, Odendaal HJ, Steyn DW, et al. Expectant management of early onset, severe pre-eclampsia: maternal outcome. BJOG 2000;107:1252-7.
16. Ryan TP. Sample Size Determination and Power. Hoboken, New Jersey: John Wiley and Sons, Inc; 2013.
17. World Health Organization. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. WHO Tech Rep Ser 1995;850:97-137.
18. Thadhani R, Kisner T, Hagmann H, et al. Pilot study of extracorporeal removal of soluble fms-like tyrosine kinase 1 in preeclampsia. Circulation 2011;124:940-50.
19. Ramma W, Ahmed A. Therapeutic potential of statins and the induction of heme oxygenase-1 in preeclampsia. J Reprod Immunol 2014;101-102:153-60.
20. Costantine MM, Tamayo E, Lu F, et al. Using pravastatin to improve the vascular reactivity in a mouse model of soluble fms-like tyrosine kinase-1-induced preeclampsia. Obstet Gynecol 2010;116:114-20.
21. Teratology Society Public Affairs Committee. FDA classification of drugs for teratogenic risk. Teratology 1994;49:446-7.