Phase I pilot clinical trial of antenatal maternally administered melatonin to decrease the level of oxidative stress in human pregnancies affected by pre-eclampsia (PAMPR): Study protocol

BMJ Open

Volumn 3, Issue 9, 2013, Pages

  Hobson, Sebastian R ^a   Lim, Rebecca ^b   Gardiner, Elizabeth E ^b   Alers, Nicole O ^b   Wallace, Euan M ^a,b  

^a SOUTHERN HEALTH   (Australia)

^b MONASH UNIVERSITY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ACTIVIN; C REACTIVE PROTEIN; ENDOGLIN; LEUKOCYTE ELASTASE; MELATONIN; PLACENTAL GROWTH FACTOR; VASCULOTROPIN; VON WILLEBRAND FACTOR;

ARTICLE; BLOOD CLOTTING PARAMETERS; CLINICAL ARTICLE; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DELIVERY; DRUG EFFICACY; FEMALE; FETAL DOPPLER; FETAL WELL BEING; HUMAN; MATERNAL TREATMENT; MEDICAL RECORD REVIEW; OPEN STUDY; OXIDATIVE STRESS; PHASE 1 CLINICAL TRIAL; PILOT STUDY; PREECLAMPSIA; PRENATAL CARE;

EID: 84885367610     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2013-003788     Document Type: Article

References (23)

1. Lowe SA, Brown MA, Dekker GA, et al. Guidelines for the management of hypertensive disorders of pregnancy 2008. Aust N Z J Obstet Gynaecol 2009;49:242-6.
2. Payne B, Magee LA, von Dadelszen P. Assessment, surveillance and prognosis in pre-eclampsia. Best Pract Res Clin Obstet Gynaecol 2011;25:449-62.
3. Roberts JM, Gammill HS. Preeclampsia: recent insights. Hypertension 2005;46:1243-9. (Pubitemid 43189714)
4. Steegers EA, von Dadelszen P, Duvekot JJ, et al. Pre-eclampsia. Lancet 2010;376:631-44.
5. Burton GJ, Jauniaux E. Oxidative stress. Best Pract Res Clin Obstet Gynaecol 2011;25:287-99.
6. Reiter RJ, Tan DX. Melatonin: a novel protective agent against oxidative injury of the ischemic/reperfused heart. Cardiovasc Res 2003;58:10-19. (Pubitemid 36351618)
7. Reiter RJ, Tan DX, Osuna C, et al. Actions of melatonin in the reduction of oxidative stress. A review. J Biomed Sci 2000;7:444-58.
8. Miller SL, Yan EB, Castillo-Melendez M, et al. Melatonin provides neuroprotection in the late-gestation fetal sheep brain in response to umbilical cord occlusion. Dev Neurosci 2005;27:200-10. (Pubitemid 41096227)
9. Welin AK, Svedin P, Lapatto R, et al. Melatonin reduces inflammation and cell death in white matter in the mid-gestation fetal sheep following umbilical cord occlusion. Pediatr Res 2007;61:153-8. (Pubitemid 46146871)
10. Gitto E, Pellegrino S, Gitto P, et al. Oxidative stress of the newborn in the pre- and postnatal period and the clinical utility of melatonin. J Pineal Res 2009;46:128-39.
11. Fulia F, Gitto E, Cuzzocrea S, et al. Increased levels of malondialdehyde and nitrite/nitrate in the blood of asphyxiated newborns: reduction by melatonin. J Pineal Res 2001;31:343-9. (Pubitemid 33032950)
12. Lanoix D, Guerin P, Vaillancourt C. Placental melatonin production and melatonin receptor expression are altered in preeclampsia: new insights into the role of this hormone in pregnancy. J Pineal Res 2012;53:417-25.
13. Lanoix D, Beghdadi H, Lafond J, et al. Human placental trophoblasts synthesize melatonin and express its receptors. J Pineal Res 2008;45:50-60. (Pubitemid 351986262)
14. Miller SL, Wallace EM, Walker DW. Antioxidant therapies: a potential role in perinatal medicine. Neuroendocrinology 2012;96:13-23.
15. Okatani Y, Wakatsuki A, Shinohara K, et al. Melatonin protects against oxidative mitochondrial damage induced in rat placenta by ischemia and reperfusion. J Pineal Res 2001;31:173-8. (Pubitemid 32778167)
16. Richter HG, Hansell JA, Raut S, et al. Melatonin improves placental efficiency and birth weight and increases the placental expression of antioxidant enzymes in undernourished pregnancy. J Pineal Res 2009;46:357-64.
17. Tamura H, Nakamura Y, Terron MP, et al. Melatonin and pregnancy in the human. Reprod Toxicol 2008;25:291-303.
18. Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci 2010;14:555-61.
19. Unfer V, Raffone E, Rizzo P, et al. Effect of a supplementation with myo-inositol plus melatonin on oocyte quality in women who failed to conceive in previous in vitro fertilization cycles for poor oocyte quality: a prospective, longitudinal, cohort study. Gynecol Endocrinol 2011;27:857-61.
20. Okatani Y, Okamoto K, Hayashi K, et al. Maternal-fetal transfer of melatonin in pregnant women near term. J Pineal Res 1998;25:129-34. (Pubitemid 28430591)
21. Barchas J, DaCosta F, Spector S. Acute pharmacology of melatonin. Nature 1967;214:919-20.
22. Silman RE. Melatonin: a contraceptive for the nineties. Eur J Obstet Gynecol Reprod Biol 1993;49:3-9. (Pubitemid 23233158)
23. Jahnke G, Marr M, Myers C, et al. Maternal and developmental toxicity evaluation of melatonin administered orally to pregnant Sprague-Dawley rats. Toxicol Sci 1999;50:271-9. (Pubitemid 29407090)