HemorrhageNCT00147420
RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
A study testing Zhi Byed 11 in people with Hemorrhage, run by NICHD Global Network for Women's and Children's Health at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Zhi Byed 11
- How many people
- 848 participants
- Where
- 3 sitesChina
- Study dates
- Sep 2005to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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]
- maternal history of bleeding disorders
- known allergies to any medications (severe chronic allergic conditions)
- body temperature greater than 38ºC
- asthma (asthma requiring treatment)
- mental disability
- unable to focus on consent process due to imminent delivery
- To be eligible for participation as a care provider, the participant must satisfy the following criteria:
- obstetrical care provider to pregnant woman in the study
- at least 18 years of age
- must be a physician or nurse midwife
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Lhasa Maternal-Child Health (MCH) Hospital
Lhasa
Lhasa Municipal Hospital
Lhasa
The Mentzikhang Traditional Tibetan Medicine and Astrology Hospital
Lhasa
About this study
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.
Read the 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.
- Conditions
- Hemorrhage
- Being tested
- Zhi Byed 11
- Keywords
- Tibet, Third Stage Labor, Post Partum Hemorrhage, Misoprostol, Zhi Byed 11, Global Network
- Medical subject headings
- Hemorrhage, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zhi Byed 11Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum hemorrhage
Maternal death
Secondary outcomes (1)
Estimated average blood loss of women during birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 848 participants
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Utah, Health Bureau Tibet Autonomous Region, University of California, San Francisco, One Heart Project
- Responsible party
- Sponsor
- Investigators
- Michael Varner, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147420
- Sponsor's protocol ID
- GN 10
- Status last verified
- Dec 2013
- First submitted
- 2 Sep 2005
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
- ClinicalTrials.gov ID
- NCT00147420
- Acronym / sponsor ID
- GN 10
- Conditions
- Hemorrhage
- Keywords
- Tibet, Third Stage Labor, Post Partum Hemorrhage, Misoprostol, Zhi Byed 11, Global Network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Utah, Health Bureau Tibet Autonomous Region, University of California, San Francisco, One Heart Project
- Study start
- Sep 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zhi Byed 11 | Drug | – |
Primary outcome
Postpartum hemorrhage
Maternal death
1 secondary outcome
Estimated average blood loss of women during birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Global Network for Women and Children's Health ResearchLink provided by the sponsor.
- Health Education and Research in TibetLink provided by the sponsor.
- Research Triangle Institute InternationalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Varner, MD principal investigator
University of Utah
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zhi Byed 11 in people with Hemorrhage, run by NICHD Global Network for Women's and Children's Health at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum hemorrhage. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.