RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
1 other identifier
interventional
848
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2005
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedDecember 17, 2013
December 1, 2013
September 2, 2005
December 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postpartum hemorrhage
Maternal death
Secondary Outcomes (1)
Estimated average blood loss of women during birth
Interventions
Eligibility Criteria
You may not qualify if:
- Adult, pregnant women who satisfy all the following criteria may be enrolled in the study. Pregnant women:
- who are delivering during the study period at one of the three hospitals
- who are 18 years of age or older at the time of delivery
- who are 28 weeks or more pregnant
- who are likely to have a normal vaginal delivery
- with singleton intrauterine pregnancy with vertex presentation either in early labor or in anticipation of induction of labor, and
- whose fetus is alive (has a heart rate \>100bpm) at the time of screening
- who are able to give informed consent.
- Any of the following criteria will exclude a woman from study participation:
- pre-term labor (\<28 weeks)
- previous or planned cesarean delivery
- current multiple gestations
- active hemorrhaging
- severe anemia (Hgh \<7)
- hypertension (persistent BP\>140/90 or greater OR hypertension requiring treatment) \[this criteria was omitted mid-study\]
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NICHD Global Network for Women's and Children's Healthlead
- Global Network for Women's and Children's Health Researchcollaborator
- Bill and Melinda Gates Foundationcollaborator
- Fogarty International Center of the National Institute of Healthcollaborator
- National Center for Complementary and Integrative Health (NCCIH)collaborator
- National Institute of Dental and Craniofacial Research (NIDCR)collaborator
- National Cancer Institute (NCI)collaborator
- RTI Internationalcollaborator
- University of Utahcollaborator
- Health Bureau Tibet Autonomous Regioncollaborator
- University of California, San Franciscocollaborator
- One Heart Projectcollaborator
Study Sites (3)
Lhasa Maternal-Child Health (MCH) Hospital
Lhasa, China
Lhasa Municipal Hospital
Lhasa, China
The Mentzikhang Traditional Tibetan Medicine and Astrology Hospital
Lhasa, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Varner, MD
University of Utah
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
September 1, 2005
Study Completion
March 1, 2007
Last Updated
December 17, 2013
Record last verified: 2013-12