RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Michael Varner, MD
University of Utah
United States: Federal Government