Randomized double masked trial of Zhi Byed 11, a Tibetan traditional medicine, versus misoprostol to prevent postpartum hemorrhage in Lhasa, Tibet.
J Midwifery Womens Health. 2009 Mar-Apr;54(2):133-141.e1. PMID: 19249659
Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, 50 Beale St., Ste. 1200, San Francisco, CA 94105, USA. firstname.lastname@example.org
The objective of this study was to compare a Tibetan traditional medicine (the uterotonic Zhi Byed 11 [ZB11]) to oral misoprostol for prophylaxis of postpartum hemorrhage (PPH). We conducted a double-blind randomized controlled trial at three hospitals in Lhasa, Tibet, People's Republic of China. Women (N = 967) were randomized to either ZB11 or misoprostol groups. Postpartum blood loss was measured in a calibrated blood collection drape. The primary combined outcome was incidence of PPH, defined as measured blood loss (MBL)>or = 500 mL, administration of open label uterotonics, or maternal death. We found that the rate of the combined outcome was lower among the misoprostol group (16.1% versus 21.8% for ZB11; P = .02). Frequency of PPH was lower with misoprostol (12.4% versus 17.4%; P = .02). There were no significant differences in MBL>1000 mL or mean or median MBL. Fever was significantly more common in the misoprostol group (P = .03). The rate of combined outcome was significantly lower among women receiving misoprostol. However, other indices of obstetric hemorrhage were not significantly different.