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Procedures of Informed Consent are considered a high priority for international biomedical research. However, informed consent protocols are not necessarily transferable across cultural, national or ethnic groups. Recent debates identify the need for balancing ethical universals with practical and local conditions and paying attention to questions of cultural competence when it comes to the Informed Consent process for clinical biomedical research. This article reports on the results of a two-year effort to establish a culturally appropriate Informed Consent process for biomedical research in the Tibet Autonomous Region in the People's Republic of China. A team of Tibetan and American researchers, physicians, health professionals and medical anthropologists conducted the research. The Informed Consent was specifically for undertaking a triple-blind, double placebo-controlled randomized clinical trial of a Tibetan medicine compared with Misoprostol for reducing postpartum blood loss. The findings suggest greater need for flexibility and cooperation in establishing Informed Consent protocols across cultures and nations.
<i>Introduction</i>: To determine the outcomes of vaginal deliveries in three study hospitals in Lhasa, Tibet Autonomous Region (TAR), People's Republic of China (PRC), at high altitude (3650 m). <i>Methods</i>: Prospective observational study of 1121 vaginal deliveries. <i>Results</i>: Pre-eclampsia/gestational hypertension (PE/GH) was the most common maternal complication 18.9% (<i>n</i> = 212), followed by postpartum hemorrhage (blood loss ≥ 500 ml) 13.4%. There were no maternal deaths. Neonatal complications included: low birth weight (10.2%), small for gestational age (13.7%), pre-term delivery (4.1%) and low Apgar (3.7%). There were 11 stillbirths (9.8/1000 live births) and 19 early neonatal deaths (17/1000 live births). <i>Conclusion</i>: This is the largest study of maternal and newborn outcomes in Tibet. It provides information on the outcomes of institutional vaginal births among women delivering infants at high altitude. There was a higher incidence of PE/GH and low birth weight; rates of PPH were not increased compared to those at lower altitudes.
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.