RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet|
- Postpartum hemorrhage
- Maternal death
- Estimated average blood loss of women during birth
|Study Start Date:||September 2005|
|Study Completion Date:||March 2007|
Post-partum hemorrhage (PPH) is one of the main direct causes of maternal mortality, particularly in rural areas with low access to skilled providers, blood banks, and surgical facilities. In addition to the mortality, PPH also accounts for a great number of morbidities, including anemia, renal and pulmonary problems, fatigue, and decreased resistance to infection, all major health problems affecting women in the TAR. Clinical research is rare in the Tibetan Autonomous Region (TAR) of the People's Republic of China. This trial will estimate the effect of prophylactic oral ZB 11 administered at the beginning of the second stage of labor versus prophylactic oral misoprostol, administered in the third stage of labor, in reducing the incidence of postpartum hemorrhage (defined as a measured blood loss of > 500 cc).
An observational postpartum blood measurement study was conducted. This included data collection on deliveries in three TAR hospital in Lhasa, piloting of consent forms and data collection instruments, and training in the use of a plastic drape for the measurement of postpartum blood loss.
This randomized, double masked trial will test the hypothesis that misoprostol is more effective than ZB11 in reducing the frequency of postpartum hemorrhage (defined as either a measured blood loss of > 500cc or administration of open label uterotonics within the one hour observation period after delivery).
An original sample of 848 women was increased and 967 consenting women were randomized (1:1) to a ZB11 or misoprostol arm. Since ZB 11 and misoprostol must be administered at different times, participants will receive either active ZB 11 or corresponding placebo at full dilation and active misoprostol or corresponding placebo immediately following the birth of the baby. The effectiveness of the study drug will be estimated by the postpartum blood loss that will be measured on all enrolled women with a blood collection drape.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147420
|Lhasa Maternal-Child Health (MCH) Hospital|
|Lhasa Municipal Hospital|
|The Mentzikhang Traditional Tibetan Medicine and Astrology Hospital|
|Principal Investigator:||Michael Varner, MD||University of Utah|