Ethics and social acceptability of a proposed clinical trial using maternal gene therapy to treat severe early-onset fetal growth restriction

Ultrasound in Obstetrics and Gynecology

Volumn 47, Issue 4, 2016, Pages 484-491

  Sheppard, M ^a   Spencer, R N ^b   Ashcroft, R ^a   David, A L ^b  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

ethics; fetal growth restriction; gene therapy; pregnancy; qualitative; translational medicine

Indexed keywords

VASCULOTROPIN A;

CLINICAL TRIAL (TOPIC); ETHICS; EUROPE; FEMALE; FETAL GROWTH RETARDATION; FETAL THERAPY; GENE THERAPY; GENETICS; HUMAN; PREGNANCY; PROCEDURES; UTERINE ARTERY;

CLINICAL TRIALS AS TOPIC; EUROPE; FEMALE; FETAL GROWTH RETARDATION; FETAL THERAPIES; GENETIC THERAPY; HUMANS; PREGNANCY; UTERINE ARTERY; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84960359023     PISSN: 09607692     EISSN: 14690705     Source Type: Journal    
DOI: 10.1002/uog.15880     Document Type: Article

References (20)

1. Spencer RN, Carr DJ, David AL,. Treatment of poor placentation and the prevention of associated adverse outcomes-what does the future hold? Prenat Diagn 2014; 34: 677-684.
2. Marsal K., Obstetric management of intrauterine growth restriction. Best Pract Res Clin Obstet Gynaecol 2009; 23: 857-870.
3. EVERREST Consortium. EVERREST: Maternal growth factor therapy to improve fetal growth. Available from: www.everrest-fp7.eu [updated; cited 2 July 2014].
4. David AL, Torondel B, Zachary I, Wigley V, Abi-Nader K, Mehta V, Buckley SM, Cook T, Boyd M, Rodeck CH, Martin J, Peebles DM,. Local delivery of VEGF adenovirus to the uterine artery increases vasorelaxation and uterine blood flow in the pregnant sheep. Gene Ther 2008; 15: 1344-1350.
5. Mehta V, Abi-Nader KN, Peebles DM, Benjamin E, Wigley V, Torondel B, Filippi E, Shaw SW, Boyd M, Martin J, Zachary I, David AL,. Long-term increase in uterine blood flow is achieved by local overexpression of VEGF-A(165) in the uterine arteries of pregnant sheep. Gene Ther 2012; 19: 925-935.
6. Mehta V, Abi-Nader KN, Shangaris P, Shaw SW, Filippi E, Benjamin E, Boyd M, Peebles DM, Martin J, Zachary I, David AL,. Local over-expression of VEGF-DDeltaNDeltaC in the uterine arteries of pregnant sheep results in long-term changes in uterine artery contractility and angiogenesis. PloS One 2014; 9: e100021.
7. Carr D, Wallace JM, Aitken RP, Milne JS, Mehta V, Martin JF, Zachary IC, Peebles D, David AL,. Uteroplacental adenovirus VEGF gene therapy increases fetal growth velocity in growth-restricted sheep pregnancies. Hum Gene Ther 2014; 25: 375-384.
8. Hutton J, Ashcroft R,. What does 'systematic' mean for reviews of methods? In Health Services Research Methods: A Guide to Best Practice, Black N, Brazier R, Fitzpatrick R, Reeves B, (eds). BMJ Books: London, 1998. 249-254.
9. Pope C, Mays N,. Qualitative Research in Health Care (III edn). BMJ Publishing: Oxford, 2006.
10. Dickenson DL,. Ethical Issues in Maternal-Fetal Medicine. Cambridge University Press: Cambridge, 2002.
11. Chervenak FA, McCullough LB,. An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. Am J Bioeth 2011; 11: 39-49.
12. Mahowald MB,. Bioethics and Women: Across the Lifespan. Oxford University Press: Oxford, 2006.
13. Mason J., The Troubled Pregnancy: Legal Wrongs and Rights in Reproduction. Cambridge University Press: Cambridge, 2007.
14. Hervey TK, McHale JV,. Health Law and the European Union. Cambridge University Press: Cambridge, 2004.
15. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013; 310: 2191-2194.
16. Kenyon S, Dixon-Woods M, Jackson CJ, Windridge K, Pitchforth E,. Participating in a trial in a critical situation: a qualitative study in pregnancy. Qual Saf Health Care 2006; 15: 98-101.
17. Smyth RM, Jacoby A, Elbourne D,. Deciding to join a perinatal randomised controlled trial: experiences and views of pregnant women enroled in the Magpie Trial. Midwifery 2012; 28: E478-485.
18. Morris RK, Malin GL, Quinlan-Jones E, Middleton LJ, Diwakar L, Hemming K, Burke D, Daniels J, Denny E, Barton P, Roberts TE, Khan KS, Deeks JJ, Kilby MD,. The Percutaneous shunting in Lower Urinary Tract Obstruction (PLUTO) study and randomised controlled trial: evaluation of the effectiveness, cost-effectiveness and acceptability of percutaneous vesicoamniotic shunting for lower urinary tract obstruction. Health Technol Assess 2013; 17: 1-232.
19. Oude Rengerink K, Logtenberg S, Hooft L, Bossuyt PM, Mol BW,. Pregnant womens' concerns when invited to a randomized trial: a qualitative case control study. BMC Pregnancy Childbirth 2015; 15: 207.
20. Lavender T, Kingdon C,. Primigravid women's views of being approached to participate in a hypothetical term cephalic trial of planned vaginal birth versus planned cesarean birth. Birth 2009; 36: 213-219.