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

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Utah
Health Bureau Tibet Autonomous Region
University of California, San Francisco
One Heart Project
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00147420
First received: September 2, 2005
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Hemorrhage
Drug: Zhi Byed 11

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Postpartum hemorrhage
  • Maternal death

Secondary Outcome Measures:
  • Estimated average blood loss of women during birth

Estimated Enrollment: 848
Study Start Date: September 2005
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147420

Locations
China
The Mentzikhang Traditional Tibetan Medicine and Astrology Hospital
Lhasa, China
Lhasa Municipal Hospital
Lhasa, China
Lhasa Maternal-Child Health (MCH) Hospital
Lhasa, China
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Utah
Health Bureau Tibet Autonomous Region
University of California, San Francisco
One Heart Project
Investigators
Principal Investigator: Michael Varner, MD University of Utah
  More Information

Additional Information:
No publications provided

Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00147420     History of Changes
Other Study ID Numbers: GN 10
Study First Received: September 2, 2005
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Tibet
Third Stage Labor
Post Partum Hemorrhage
Misoprostol
Zhi Byed 11
Global Network

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on September 18, 2014