Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
848 participants
INTERVENTIONAL
2005-09-30
2007-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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Zhi Byed 11
Eligibility Criteria
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Exclusion Criteria
* 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) \[this criteria was omitted mid-study\]
* 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
18 Years
FEMALE
Yes
Sponsors
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Global Network for Women's and Children's Health Research
OTHER
Bill and Melinda Gates Foundation
OTHER
Fogarty International Center of the National Institute of Health
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
National Cancer Institute (NCI)
NIH
RTI International
OTHER
University of Utah
OTHER
Health Bureau Tibet Autonomous Region
UNKNOWN
University of California, San Francisco
OTHER
One Heart Project
UNKNOWN
NICHD Global Network for Women's and Children's Health
NETWORK
Responsible Party
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Principal Investigators
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Michael Varner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Lhasa Maternal-Child Health (MCH) Hospital
Lhasa, , China
Lhasa Municipal Hospital
Lhasa, , China
The Mentzikhang Traditional Tibetan Medicine and Astrology Hospital
Lhasa, , China
Countries
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Related Links
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Global Network for Women and Children's Health Research
Research Triangle Institute International
Other Identifiers
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GN 10
Identifier Type: -
Identifier Source: org_study_id