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

December 16, 2013 updated by: NICHD Global Network for Women's and Children's Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

848

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Lhasa, China
        • Lhasa Maternal-Child Health (MCH) Hospital
      • Lhasa, China
        • Lhasa Municipal Hospital
      • Lhasa, China
        • The Mentzikhang Traditional Tibetan Medicine and Astrology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Postpartum hemorrhage
Maternal death

Secondary Outcome Measures

Outcome Measure
Estimated average blood loss of women during birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Global Network for Women's and Children's Health

Collaborators

National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Bill and Melinda Gates Foundation
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
University of Utah
Fogarty International Center of the National Institute of Health
RTI International
Global Network for Women's and Children's Health Research
Health Bureau Tibet Autonomous Region
One Heart Project

Investigators

  • Principal Investigator: Michael Varner, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN 10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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