151932 Randomized double blind trial of Zhi Byed 11, a Tibetan traditional medicine, versus misoprostol to prevent postpartum hemorrhage in Lhasa, Tibet

Tuesday, November 6, 2007

Carrie Tudor, MPH , OB/GYN and Reproductive Sciences, University of California, San Francisco, San Francisco, CA
Michael W. Varner, MD , University of Utah Health Sciences Center-, University of Utah, Salt Lake City, UT
Nyima La, MD , Women's Department, Lhasa Municipal Hospital, Lhasa, TAR, China
Sonam La, MD , Women's Department, Mentzikhang Traditional Tibetan Medicine and Astrology Hospital, Lhasa, TAR, China
Droyoung La, MD , Women's Department, Lhasa Maternal Child Health Hospital, Lhasa, TAR, China
Gelyang La, MD , Women's Department, Lhasa Municipal Hospital, Lhasa, TAR, China
Karma Quzong , Women's Department, Lhasa Maternal Child Health Hospital, Lhasa, TAR, China
Lhakpen La, MD , Women's Department, Mentzikhang Traditional Tibetan Medicine and Astrology Hospital, Lhasa, TAR, China
Vanessa Thorsten, MPH , RTI International, Research Triangle Park, NC
Linda L. Wright , Center for Research for Mothers and Children NICHD, NIH, Rockville, MD
Suellen Miller, PhD, CNM , OB/GYN and Reproductive Sciences, University of California, San Francisco, San Francisco, CA
Background: In the Tibet Autonomous Region (TAR) of China, where 85% of deliveries occur at home, postpartum hemorrhage (PPH) is the leading cause of maternal mortality. Zhi byed 11 (ZB 11), a traditional Tibetan medicine, has been used in Tibet for over 700 years to decrease obstetric hemorrhage.

Objectives: To test the hypothesis that 600 micrograms oral misoprostol is more effective than ZB 11 in reducing the frequency of measured blood loss >= 500 mL, administration of open label uterotonics within one hour after delivery, or maternal death.

Methods: Prospective double blind, double placebo randomized trial of women (n=900) delivering vaginally in three hospitals in Lhasa, Tibet between August 2005 and March 2007. All women received only one active medication; either ZB 11 study drug or misoprostol study drug and one placebo. No woman received both active study medications or two placebos. Postpartum blood loss was collected in a closed-end blood collection drape for one-hour following the delivery of the newborn. Side-effects were monitored for one hour post administration.

Results and conclusions: This NICHD funded trial has yet to be completed and therefore the results by treatment group cannot be included in this abstract. Data analysis is scheduled to be completed by May 2007.

Learning Objectives:
1. Describe the outcomes of a double-blind, double placebo randomized clinical controlled trial (RCT) of a traditional Tibetan medicine used as a uterotonic vs. misoprostol on postpartum blood loss in Tibet. 2. Describe other important secondary outcomes of the ZB 11 vs. misoprostol RCT.

Keywords: Safe Mother Program, Pregnancy Outcomes

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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