RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet

Not Applicable

Completed

• Conditions: Hemorrhage

• Registration Number: NCT00147420
• Lead Sponsor: NICHD Global Network for Women's and Children's Health

Brief Summary

Previous research has confirmed that hemorrhage is among the most commonly encountered pregnancy complications in the Tibet Autonomous Region (TAR). This trial will test the effectiveness of a traditional Tibetan drug (Zhi Byed 11) vs. misoprostol to prevent postpartum hemorrhage (PPH) among women delivering vaginally in three hospitals in Lhasa, TAR.

Detailed Description

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Study Completion: 2007-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 848

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal death
Postpartum hemorrhage

Secondary Outcome Measures

Name	Time	Method
Estimated average blood loss of women during birth

Trial Locations

Locations (3)

The Mentzikhang Traditional Tibetan Medicine and Astrology Hospital; 🇨🇳 Lhasa, China

Lhasa Maternal-Child Health (MCH) Hospital; 🇨🇳 Lhasa, China

Lhasa Municipal Hospital; 🇨🇳 Lhasa, China