Status:
COMPLETED
RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborating Sponsors:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
Conditions:
Hemorrhage
Eligibility:
FEMALE
18+ years
Phase:
NA
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 traditi...
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...
Eligibility Criteria
Inclusion
- Inclusion and Exclusion Criteria
- 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) \[this criteria was omitted mid-study\]
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
848 Patients enrolled
Trial Details
Trial ID
NCT00147420
Start Date
September 1 2005
End Date
March 1 2007
Last Update
December 17 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Lhasa Maternal-Child Health (MCH) Hospital
Lhasa, China
2
Lhasa Municipal Hospital
Lhasa, China
3
The Mentzikhang Traditional Tibetan Medicine and Astrology Hospital
Lhasa, China