Randomized Double Masked Trial of Zhi Byed 11, a Tibetan Traditional Medicine, Versus Misoprostol to Prevent Postpartum Hemorrhage in Lhasa, Tibet

Journal of Midwifery and Women's Health

Volumn 54, Issue 2, 2009, Pages 133-141

  Miller, Suellen ^a   Tudor, Carrie ^a   Thorsten, Vanessa ^a   Nyima, ^a   Kalyang, ^a   Sonam, ^a   Lhakpen, ^a   Droyoung, ^a   Quzong, Karma ^a   Dekyi, Tsering ^a   Hartwell, Ty ^a   Wright, Linda L ^a   Varner, Michael W ^a  

^a NONE

Author keywords

complementary medicine; obstetric hemorrhage; postpartum hemorrhage; randomized controlled trial

Indexed keywords

CHINESE DRUG; MISOPROSTOL; PLACEBO;

ADULT; ARTICLE; BLOOD SAMPLING; CHINA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; FEMALE; FEVER; HUMAN; MAJOR CLINICAL STUDY; MATERNAL MORTALITY; MULTICENTER STUDY; NAUSEA AND VOMITING; POSTPARTUM HEMORRHAGE; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; SHIVERING; TRADITIONAL MEDICINE; TREATMENT OUTCOME;

EID: 60649089263     PISSN: 15269523     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jmwh.2008.09.010     Document Type: Article

References (45)

1. World Health Organization. The world health report 2005: Make every mother and child count (2005), World Health Organization, Geneva
2. Liang J., Wang Y.P., Wu Y.Q., Zhou G.X., Zhu J., Dai L., et al. Maternal mortality in rural areas of China. Sichuan Da Xue Xue Bao Yi Xue Ban 35 (2004) 258-260
3. Tshomo M. Knowledge of pregnancy and delivery and obstetrical diseases and treatments from a Tibetan medical perspective [master's thesis] (2004), Tibetan Medical College, Lhasa, Tibet
4. Duke J. Phytochemical and ethnobotanical databases. Available from: www.ars-grin.gov/duke/ [Accessed August 1, 2007].
5. University of Utah Center for Human Toxicology. Solid material sample; analysis consultant case CC-20-03 (2003), July 31, Salt Lake City, UT
6. Tudor C., Miller S., Nyima, Sonam, Droyoung, and Varner M. Preliminary progress report: Randomized double-blind trial of Zhi Byed 11, a Tibetan traditional medicine, versus misoprostol to prevent postpartum hemorrhage in Lhasa, Tibet. Int J Gynaecol Obstet 94 Suppl 2 (2006) S145-S146
7. Horton E.W. Hypotheses on physiological roles of prostaglandins. Physiol Rev 49 (1969) 122-161
8. Horton E.W. Physiological roles of the prostaglandins. Sci Basis Med Annu Rev (1970) 51-60
9. Horton E.W. Prostaglandins. Monogr Endocrinol 7 (1972) 1-197
10. Otsuki T., and Oku M. A study on the effect of cortisol and progesterone on cytosolic arachidonic and palmitic acid concentrations in cultured human myometrial cells. Nippon Sanka Fujinka Gakkai Zasshi 47 (1995) 531-538
11. Pendergraft J.S., O'Brien W.F., and Williams M.C. Modulators of prostaglandin E2 synthesis in human amnion. J Soc Gynecol Investig 1 (1994) 131-134
12. Barnes J., Anderson L., and Phillipson J. Herbal medicines: A guide for health care professionals (2007), Pharmaceutical Press, London, UK
13. Cook W. The physiomedical dispensatory (1869), Self-published, Cincinnati, OH
14. Adams V., Miller S., Chertow J., Craig S., Samen A., and Varner M. Having a "safe delivery": Conflicting views from Tibet. Health Care Women Int 26 (2005) 821-851
15. Lhasa Municipality Health Bureau, 2003.
16. International Confederation of Midwives Web site. International Confederation of Midwives and the International Federation of Gynecology and Obstetrics. Joint statement: Management of the third stage of labour to prevent post-partum haemorrhage. Available from: www.internationalmidwives.org/modules/ContentExpress/img_repository/final%20joint%20statement%20active%20manangement-eng%20with%20logo.pdf [Accessed October 13, 2008].
17. Gulmezoglu A.M., Villar J., Ngoc N.T., Piaggio G., Carroli G., Adetoro L., et al. WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. Lancet 358 (2001) 689-695
18. 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. Br J Obstet Gynaecol 112 (2005) 1277-1283
19. Derman R.J., Kodkany B.S., Goudar S.S., Geller S.E., Naik V.A., Bellad M., et al. Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: A randomised controlled trial. Lancet 368 (2006) 1248-1253
20. Hofmeyr G.J., Nikodem V.C., de Jager M., and Gelbart B.R. A randomised placebo controlled trial of oral misoprostol in the third stage of labour. Br J Obstet Gynaecol 105 (1998) 971-975
21. Høj L., Cardoso P., Nielsen B.B., Hvidman L., Nielsen J., and Aaby P. Effect of sublingual misoprostol on severe postpartum haemorrhage in a primary health centre in Guinea-Bissau: Randomised double blind clinical trial. BMJ 331 (2005) 723
22. Surbek D.V., Fehr P.M., Hosli I., and Holzgreve W. Oral misoprostol for third stage of labor: A randomized placebo-controlled trial. Obstet Gynecol 94 (1999) 255-258
23. International Federation of Gynecology and Obstetrics Web site. International Confederation of Midwives and the International Federation of Gynecology and Obstetrics. Joint statement: Prevention and treatment of post-partum haemorrhage. New advances for low resource settings. Available from: www.figo.org/docs/PPH%20Joint%20Statement%202%20English.pdf [Accessed October 13, 2008].
24. Chandhiok N., Dhillon B.S., Datey S., Mathur A., and Saxena N.C. Oral misoprostol for prevention of postpartum hemorrhage by paramedical workers in India. Int J Gynaecol Obstet 92 (2006) 170-175
25. Hofmeyr G.J., Ferreira S., Nikodem V.C., Mangesi L., Singata M., Jafta Z., et al. Misoprostol for treating postpartum haemorrhage: A randomized controlled trial [ISRCTN72263357]. BMC Pregnancy Childbirth 4 (2004) 16
26. Lumbiganon P., Hofmeyr J., Gulmezoglu A.M., Pinol A., and Villar J. Misoprostol dose-related shivering and pyrexia in the third stage of labour. WHO Collaborative Trial of Misoprostol in the Management of the Third Stage of Labour. Br J Obstet Gynaecol 106 (1999) 304-308
27. Tibetan Centre for Human Rights and Democracy Web site. Behind bars: Prison conditions in Tibet. Impoverishing Tibetans. II. Poverty in Tibet. Available from: www.tchrd.org/publications/topical_reports/impoverishing_tibetans-2000/2_poverty.html [Accessed August 1, 2007].
28. Xinhua News Agency Web site. Facts & figures: Tibet's population. Available from: http://news.xinhuanet.com/english/2008-04/11/content_7960090.htm [Accessed October 13, 2008].
29. Adams V., Miller S., Craig S., Samen A., Nyima, Lhakpen, et al. The challenge of cross-cultural clinical trials research: Case report from the Tibetan Autonomous Region, People's Republic of China. Med Anthropol Q 19 (2005) 267-289
30. Adams V., Miller S., Craig S., Le P.V., Samen A., Sonam, et al. Informed consent in cross-cultural perspective: Clinical research in the Tibetan Autonomous Region, PRC. Cult Med Psychiatry 31 (2007) 445-472
31. Miller S., Tudor C., Nyima, Thorsten V.R., Sonam, Droyoung, et al. Maternal and neonatal outcomes of hospital vaginal deliveries in Tibet. Int J Gynaecol Obstet 98 (2007) 217-221
32. Miller S., Le P., Craig S., Adams V., Tudor C., Sonam, et al. How to make consent informed: Possible lessons from Tibet. IRB 29 (2007) 7-14
33. US Food and Drug Administration Web site. Misoprostol (marketed as Cytotec) information. Available from: http://www.fda.gov/cder/drug/infopage/misoprostol/default.htm [Accessed October 13, 2008].
34. Gerancher J.C., Grice S.C., Dewan D.M., and Eisenach J. An evaluation of informed consent prior to epidural analgesia for labor and delivery. Int J Obstet Anesth 9 (2000) 168-173
35. Vernon G., Alfirevic Z., and Weeks A. Issues of informed consent for intrapartum trials: A suggested consent pathway from the experience of the Release trial [ISRCTN13204258]. Trials 7 (2006) 13
36. University of Utah Center for Human Toxicology. Pill capsules; placebo, ZB 11; analysis, consultant case CC-30-04 (2004), October 22, Salt Lake City, UT
37. Patel A., Goudar S.S., Geller S.E., Kodkany B.S., Edlavitch S.A., Wagh K., et al. Drape estimation vs. visual assessment for estimating postpartum hemorrhage. Int J Gynaecol Obstet 93 (2006) 220-224
38. Azhari S., Pirdadeh S., Lotfalizadeh M., and Shakeri M.T. Evaluation of the effect of castor oil on initiating labor in term pregnancy. Saudi Med J 27 (2006) 1011-1014
39. Davis L. The use of castor oil to stimulate labor in patients with premature rupture of membranes. J Nurse Midwifery 29 (1984) 366-370
40. Kaido T.L., Veale D.J., Havlik I., and Rama D.B. Preliminary screening of plants used in South Africa as traditional herbal remedies during pregnancy and labour. J Ethnopharmacol 55 (1997) 185-191
41. Kelly A.J., Kavanagh J., and Thomas J. Castor oil, bath and/or enema for cervical priming and induction of labour. Cochrane Database Syst Rev 2 (2001) CD003099
42. Blanchard K., Clark S., Winikoff B., Gaines G., Kabani G., and Shannon C. Misoprostol for women's health: A review. Obstet Gynecol 99 (2002) 316-332
43. Lachin J.M. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials 2 (1981) 93-113
44. Shih W.J., and Zhao P.L. Design for sample size re-estimation with interim data for double-blind clinical trials with binary outcomes. Stat Med 16 (1997) 1913-1923
45. O'Brien P.C., and Fleming T.R. A multiple testing procedure for clinical trials. Biometrics 35 (1979) 549-556