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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Female

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. misoprostol to prevent postpartum hemorrhage (PPH) among women delivering vaginally in three hospitals in Lhasa, TAR.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Global Network for Women's and Children's Health
• Collaborators: Bill and Melinda Gates Foundation; Fogarty International Center of the National Institute of Health; Global Network for Women's and Children's Health Research; Health Bureau Tibet Autonomous Region; John E. Fogarty International Center (FIC); National Cancer Institute (NCI); National Center for Complementary and Integrative Health (NCCIH); National Institute of Dental and Craniofacial Research (NIDCR); One Heart Project; RTI International; University of California, San Francisco; University of Utah
• Treatments: Misoprostol

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