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Randomized Controlled Trial
. 2009 Mar-Apr;54(2):133-141.e1.
doi: 10.1016/j.jmwh.2008.09.010.

Randomized double masked trial of Zhi Byed 11, a Tibetan traditional medicine, versus misoprostol to prevent postpartum hemorrhage in Lhasa, Tibet

Suellen Miller  1 , Carrie Tudor, Vanessa Thorsten, Nyima, Kalyang, Sonam, Lhakpen, Droyoung, Karma Quzong, Tsering Dekyi, Ty Hartwell, Linda L Wright, Michael W Varner
Affiliations
Randomized Controlled Trial

Randomized double masked trial of Zhi Byed 11, a Tibetan traditional medicine, versus misoprostol to prevent postpartum hemorrhage in Lhasa, Tibet

Suellen Miller et al. J Midwifery Womens Health. 2009 Mar-Apr.

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.

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Figures

Figure 1
Figure 1
Zhi Byed 11 (ZB11) ingredients.
Figure 2
Figure 2
Trial profile.
See this image and copyright information in PMC

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