Seminars in Fetal & Neonatal Medicine
Volume 11, Issue 2 , Pages 89-96 , April 2006

Perinatal research in developing countries – Is it possible?

  • Lelia Duley

      Affiliations

    • Nuffield Department of Medicine, Room 5609, Level 5, John Radcliffe Hospital, Headington, Oxford OX3 9DU, UK
    • Corresponding Author InformationCorresponding author. Tel.: +44 1865 228964; fax: +44 113 3930692.
    • ,
  • Justus Hofmeyr

      Affiliations

    • East London Hospital Complex, University of the Witwatersrand/University of Fort Hare, Private Bag X9047, East London 5201, South Africa
    • ,
  • Guillermo Carroli

      Affiliations

    • Centro Rosarino de Estudios Perinatales, Pueyrredon 985, Rosario (2000), Argentina
    • ,
  • Pisake Lumbiganon

      Affiliations

    • Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
    • ,
  • Edgardo Abalos

      Affiliations

    • Centro Rosarino de Estudios Perinatales, Pueyrredon 985, Rosario (2000), Argentina

References 

  1. Rosenfield A, Maine D. Maternal mortality-a neglected tragedy. Where is the M in MCH?. Lancet. 1985;2:83–85
  2. ∗ World Health Report 2005. Make every mother and child count. Geneva: World Health Organisation; 2005;
  3. Smith R. Publishing research from developing countries. Stat Med. 2002;21:2869–2877
  4. Tan-Torres Edejer T. The ethics of drug trials in less-developed countries. Lancet. 2000;356(Suppl.):s37
  5. Horton R. North and South: bridging the information gap. Lancet. 2000;355:2231–2236
  6. Villar J, Carroli G, Gulmezoglu M. The gap between evidence and practice in maternal health care. Int J Obstet Gynaecol. 2001;75:S47–S54
  7. Langer A, Villar J. Promoting evidence based practice in maternal care: would keep the knife away. BMJ. 2002;324:928–929
  8. Magpie Trial Follow Up Study Collaborative Group. Tracing and assessing women and children recruited to the Magpie Trial in 19 countries. eLancet, in press.
  9. ∗ Garner P, Tan Torres T, Alonso P. Trial design in developing countries. The results of studies must be relevant to the populations in which they are carried out. BMJ. 1994;309:825–826
  10. Geller SE, Patel A, Niak VA, Goudar SS, Edlavitch SA, Kodkany BS, et al. Conducting international collaborative research in developing nations. Int J Obstet Gynaecol. 2004;87:267–271
  11. ∗ Isaakidis P, Swingler G, Pienaar E, Volmink J, Ioannidis J. Relation between burden of disease and randomised evidence in sub-Saharan Africa: survey of research. BMJ. 2005;324:702–705
  12. Hamlin R. Prevention of pre-eclampsia. Lancet. 1962;i:864–865
  13. Belizan J, Villar J. The relationship between calcium intake and edema-, proteinuria-, and hypertension-getosis: an hypothesis. Am J Clin Nutr. 1980;33:2202–2210
  14. Atallah A, Hofmeyr G, Duley L. Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems [Cochrane Review]. The Cochrane Library. 2005;(1):
  15. Villar J. Calcium supplementation during pregnancy in low-intake populations [web page]. Available at http://www.controlled-trials.com/isrctn/trial/VILLAR/0/37214165.html[accessed 26 September 2005]
  16. Belizan J, Villar J, Bergel E, del Pino A, Di Fulvio S, Galliano SV, et al. Long term effect of calcium supplementation during pregnancy on the blood pressure of offspring: follow up of a randomised controlled trial. BMJ. 1997;315:281–285
  17. Mahomed K. Iron supplementation during pregnancy [Cochrane Review]. The Cochrane Library. 2005;(1):
  18. ∗ Tan-Torres Edejer T. North-South research partnerships: the ethics of carrying out research in developing countries. BMJ. 1999;319:438–441
  19. Lurie P, Wolfe S. Unethical trials of interventions to reduce perinatal transmission of the Human Immunodeficiency Virus in developing countries. N Engl J Med. 1997;337:853–856
  20. Angell M. The ethics of clinical research in the third world. N Engl J Med. 1997;337:847–849
  21. Halsey N, Sommer A, Henderson D, Black RE. Ethics of international research. BMJ. 1997;315:965–966
  22. ∗ Perinatal HIV Intervention Research in Developing Countries Workshop Census statement. Science, ethics and the future of research into maternal infant transmission of HIV-1. Lancet. 1999;353:832–835
  23. Walraven G, Blum J, Dampha Y, Sowe M, Morison L, Winikoff B, et al. Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial. BJOG. 2005;112:1277–1283
  24. Oakley A. The origins and development of antenatal care. In:  Enkin M,  Chalmers I editor. Effectiveness and satisfaction in antenatal care. Suffolk, England: Spastics International Medical Publications; 1982;p. 1–19
  25. Carroli G, Villar J, Piaggio G, Khan-Neelofur D, Gulmezoglu M, Mugford M, et al. WHO Systematic review of randomised controlled trials of routine antenatal care. Lancet. 2001;357:1565–1570
  26. ∗ Villar J, Ba'aquel H, Piaggio G, Lumbiganon P, Belzian JM, Farnot U, et al. WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care. Lancet. 2001;357:1551–1564
  27. Philpott R, Castle W. Cervicographs in the management of labour in primigravidae. II. The action line and treatment of abnormal labour. J Obstet Gynaecol Br Commonw. 1972;79:599–602
  28. Philpott R, Castle W. Cervicographs in the management of labour in primigravidae. I. The alert line for detecting abnormal labour. J Obstet Gynaecol Br Commonw. 1972;79:592–598
  29. Mariani-Neto C, Leao E, Baretto E, Kenj G, De Aquiro M. Use of misoprostol for labour induction in stillbirth. Rev Paul Med. 1987;105:325–332
  30. Matonhodze B, Alfirevic Z, Hofmeyr G, Campbell E, Brocklehurst P. Titrated oral misoprostol solution for induction of labour: a random allocation trial. J Obstet Gynaecol. 2000;20(Suppl. 1):S19
  31. Bamigboye A, Merrell D, Mitchel R, Hofmeyr G. Randomised comparison of misoprostol with syntometrine for management of third stage of labor. Acta Obstet Gynecol Scand. 1998;77:178–182
  32. Lokugamage A, Sullivan K, Niculescu I, Tigere P, Onyangunga F, El Refaey H, et al. A randomized study comparing rectally administered misoprostol versus Syntometrine combined with an oxytocin infusion for the cessation of primary post partum hemorrhage. Acta Obstet Gynecol Scand. 2001;80:835–839
  33. Bamigboye A, Hofmeyr G, Merrell D. Rectal misoprostol in the prevention of postpartum hemorrhage: a placebo-controlled trial. Am J Obstet Gynecol. 1998;179:1043–1046
  34. Hofmeyr G, Nikodem V, de Jager M, Gelbart B. A randomised placebo controlled trial of oral misoprostol in the third stage of labour. Br J Obstet Gynaecol. 1998;105:971–975
  35. The ethics industry [editorial]. Lancet. 1997;337:1003–1005
  36. World Medical Association . Declaration of Helsinki: Ethical principles for medical research involving human subjects [web page]. Available at http://www.wma.net/e/policy/b3.htm[accessed 22 September 2005]
  37. Shapiro H, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med. 2001;345:139–142
  38. NHS Centre for Reviews and Dissemination . Getting Evidence into Practice. 1999;5:1–66
  39. Freemantle N, Harvey E, Wolf F, Grimshaw J, Grilli R, Bero L. Printed educational materials: effects on professional practice and health care outcomes [Cochrane Review]. The Cochrane Library. 2005;(4):
  40. Gulmezoglu M. A randomised controlled trial to evaluate a programme promoting evidence-based medicine based on The World Health Organisation (WHO) Reproductive Health Library [web page]. Available at http://www.controlled-trials.com/isrctn/trial/GULMEZOGLU/0/14055385.html[accessed 26 September 2005]
  41. Gülmezoglu A, Villar J, Grimshaw J, Piaggio G, Lumbiganon P, Langer A. Cluster randomized trial of an active, multifaceted information dissemination intervention based on The WHO Reproductive Health Library to change obstetric practices: Methods and design issues [ISRCTN14055385]. BMC Med Res Method. 2004;4:2
  42. Gülmezoglu A., Piaggio G., Langer A., Lumbiganon P., Villar J., Grimshaw J. Cluster randomized trial of an active, multifaceted educational intervention based on the WHO Reproductive Health Library to change obstetric practices, in press.
  43. Gulmezoglu AM, Villar J, Nagoc NT, Piaggio G, Carroli G, Adetoro L, et al. WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. Lancet. 2001;358:689–695
  44. Merialdi M. Vitamins in preeclampsia (VIP): a multicentre randomized clinical trial of vitamin C and E supplementation in pregnancy for the prevention of pre-eclampsia [web page]. Available at http://www.controlled-trials.com/isrctn/trial/PREECLAMPSIA/0/86677348.html[accessed 26 September 2005]
  45. Magpie Trial Collaborative Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002;359:1877–1890
  46. Eclampsia Trial Collaborative Group. Which anticonvulsant for women with eclampsia? Evidence from the Collaborative Eclampsia Trial. Lancet. 1995;345:1455–1463
  47. Duley L. Maternal mortality associated with hypertensive disorders of pregnancy in Africa, Asia, Latin America and the Caribbean. Br J Obstet Gynaecol. 1992;99:547–553
  48. Neilson J. Magnesium sulphate: the drug of choice in eclampsia. BMJ. 1995;311:702–703
  49. Donaldson J. The case against magnesium sulphate for eclamptic convulsions. Int J Obstet Anesth. 1992;1:159–166
  50. Gulmezoglu A, Duley L. Use of anticonvulsants in eclampsia and pre-eclampsia: survey of obstetricians in the United Kingdom and Republic of Ireland. BMJ. 1998;316:975–976
  51. ∗ Jones P, Johanson R, Baldwin KJ, Lilford R, Jones P. Changing belief in obstetrics: impact of two multicentre randomised controlled trials. Lancet. 1998;352:1988–1989
  52. Waldstone M, Bewley S, Wolfe C. Incidence and predictors of severe obstetric morbidity: case-control study. BMJ. 2001;322:1089–1094
  53. Duley L on behalf of the Magpie Trial Follow Up Study Collaborative Group. Magpie Trial Follow Up Study: outcome after discharge from hospital for women and children recruited to a trial comparing magnesium sulphate with placebo for pre-eclampsia. Hypertens Pregnancy. 2004;23(Suppl. 1):17
  54. ∗ Sheth S, Chalmers I. Magnesium for preventing and treating eclampsia: time for international action. Lancet. 2002;359:1872–1873
  55. ∗ Gulmezoglu M, Villar J, Hofmeyr J, Duley L, Belizan J. Randomised trials in maternal and perinatal medicine: global partnerships are the way forward. Br J Obstet Gynaecol. 1998;105:1244–1247
  56. ∗ Duley L. Anonymity of authorship. Lancet. 1995;345:1372
  57. ∗ The important references are indicated with asterisks.

PII: S1744-165X(05)00097-1

doi: 10.1016/j.siny.2005.11.006

Seminars in Fetal & Neonatal Medicine
Volume 11, Issue 2 , Pages 89-96 , April 2006

Article Tools