title: Randomized double masked trial of Zhi Byed 11, a Tibetan traditional medicine, versus misoprostol to prevent postpartum hemorrhage in Lhasa, Tibet.
abstract: 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.
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, 50 Beale St., Ste. 1200, San Francisco, CA 94105, USA. suellenmiller@gmail.com
authors.forename: Suellen
authors.initials: S
authors.lastname: Miller
authors.forename: Carrie
authors.initials: C
authors.lastname: Tudor
authors.forename: Vanessa
authors.initials: V
authors.lastname: Thorsten
authors.lastname: Nyima
authors.lastname: Kalyang
authors.lastname: Sonam
authors.lastname: Lhakpen
authors.lastname: Droyoung
authors.forename: Karma
authors.initials: K
authors.lastname: Quzong
authors.forename: Tsering
authors.initials: T
authors.lastname: Dekyi
authors.forename: Ty
authors.initials: T
authors.lastname: Hartwell
authors.forename: Linda L
authors.initials: LL
authors.lastname: Wright
authors.forename: Michael W
authors.initials: MW
authors.lastname: Varner
mesh_terms: D000328:Adult; D000818:Animals; D002254:Carbonates; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D038861:Medicine, Tibetan Traditional; D016595:Misoprostol / Q000009:adverse effects / Q000627:therapeutic use*; D010120:Oxytocics / Q000009:adverse effects / Q000627:therapeutic use*; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D010946:Plants, Medicinal; D006473:Postpartum Hemorrhage / Q000517:prevention & control*; D011247:Pregnancy; D012911:Snakes; D013455:Sulfur; D018609:Tibet; D055815:Young Adult
chemical_list: D002254:Carbonates; D010120:Oxytocics; D028321:Plant Preparations; D016595:Misoprostol; D013455:Sulfur