Randomized Double Masked Trial of Zhi Byed 11, a Tibetan Traditional Medicine,Versus Misoprostol to Prevent Postpartum Hemorrhage in Lhasa,Tibet |
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| Authors: | Suellen Miller CNM PhD Carrie Tudor RN MPH Vanessa Thorsten MPH Nyima MD Kalyang MD Sonam MD Lhakpen MD Droyoung MD Karma Quzong Tsering Dekyi Ty Hartwell PhD Linda L. Wright MD Michael W. Varner MD |
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| Affiliation: | 1. Suellen Miller, CNM, PhD, is the Director of the Safe Motherhood Programs at the Bixby Center for Global Reproductive Health, Associate Professor, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco, and on the faculty of the Maternal and Child Health Program at the University of California Berkeley. The Safe Motherhood Program comprises intervention projects and research on critical maternal health issues.;2. Carrie Tudor, RN, MPH, is a PhD student at the Johns Hopkins University School of Nursing. During this study, she was the on‐site Project Coordinator and was affiliated with the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco.;3. Vanessa Thorsten, MPH, is associated with Research Triangle Institute International and provided data analysis for this study.;4. Nyima, MD, is the Director of the Women's Division of the Lhasa Municipal Hospital, one of the three participating hospitals in this study.;5. Kalyang, MD, is a doctor in the Lhasa Municipal Hospital, one of the three participating hospitals in this study.;6. Sonam, MD, is the Director of the Women's Division of the Mentzikhang Traditional Tibetan Medicine and Astrology Hospital, one of the three participating hospitals in this study.;7. Lhakpen, MD, is a doctor in the Women's Division of the Mentsikhang Traditional Tibetan Medicine and Astrology Hospital, one of the three participating hospitals in this study.;8. Droyoung, MD, is the Director of the Department of Obstetrics at the Lhasa Maternal‐Child Health Hospital, one of the three participating hospitals in this study.;9. Karma Quzong is a nurse in the Department of Obstetrics at the Lhasa Maternal Child Health Hospital, one of the three participating hospitals in this study.;10. Tsering Dekyi provided data entry and data management during this study in the Lhasa office.;11. Ty Hartwell, PhD, is a senior statistician affiliated with Research Triangle Institute International and provided data analysis for this study.;12. Linda L. Wright, MD, is the Deputy Director at the Center for Research for Mothers and Children at the National Institute of Child Health and Human Development in Bethesda.;13. Michael W. Varner, MD, is a Professor of Maternal and Fetal Medicine and Obstetrics & Gynecology in the University of Utah's Department of Obstetrics and Gynecology, School of Medicine and was the primary investigator on this study. |
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| Abstract: | The objective of this study was to compare a Tibetan traditional medicine (the uterotonic Zhi Byed 11 [ZB11]) to oral misoprostol for prophylaxis of postpartum hemorrhage (PPH). We conducted a double‐blind randomized controlled trial at three hospitals in Lhasa, Tibet, People's Republic of China. Women (N = 967) were randomized to either ZB11 or misoprostol groups. Postpartum blood loss was measured in a calibrated blood collection drape. The primary combined outcome was incidence of PPH, defined as measured blood loss (MBL) ≥ 500 mL, administration of open label uterotonics, or maternal death. We found that the rate of the combined outcome was lower among the misoprostol group (16.1% versus 21.8% for ZB11; P = .02). Frequency of PPH was lower with misoprostol (12.4% versus 17.4%; P = .02). There were no significant differences in MBL > 1000 mL or mean or median MBL. Fever was significantly more common in the misoprostol group (P = .03). The rate of combined outcome was significantly lower among women receiving misoprostol. However, other indices of obstetric hemorrhage were not significantly different. |
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| Keywords: | postpartum hemorrhage obstetric hemorrhage complementary medicine randomized controlled trial |
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