Treatment of Postpartum Hemorrhage
Several reports have suggested that misoprostol may be a powerful treatment for PPH both when used alone and in conjunction with standard uterotonics, however no standard regimens or protocols have been developed. Gynuity has undertaken a series of clinical trials in collaboration with international research agencies to generate reliable evidence for use of misoprostol for this indication.
Misoprostol
Gynuity, in collaboration with investigators in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam, recently completed the first large-scale, multi-site, randomized controlled clinical trials on the effectiveness of misoprostol for the treatment of primary PPH. The purpose of the trials was to ascertain whether 800mcg sublingual misoprostol is as effective as a regimen of 40 IU oxytocin (IV) in stopping hemorrhage in tertiary care facilities.
The data from these trials show that sublingual misoprostol (800 mcg) is a safe, effective and acceptable alternative first-line treatment for PPH due to uterine atony. Misoprostol is easy to administer and may be particularly useful in settings where administration of IV oxytocin is not possible, particularly at lower levels of the health care system. The results were published in the January 16th, 2010 Issue of The Lancet (Blum et al. and Winikoff et al.); the articles can be downloaded from our website (see list of Related Resources on this page).
Misoprostol Used in Combination with Other Medications
Misoprostol is also being investigated as an adjunct therapy option for postpartum bleeding. Together with the World Health Organization and its collaborating research centers in Argentina, Egypt, South Africa, Thailand, and Vietnam, Gynuity has completed a clinical trial to evaluate whether 600mcg sublingual misoprostol plus standard injectable uterotonic treatment of PPH has an additional benefit in reducing postpartum blood loss.
The data show no benefit of simultaneous administration of misoprostol + standard uterotonics over placebo + standard uterotonics for treatment of PPH. The results were published by Widmer et al. in The Lancet, Vol 375(9728):1808-1813; the article can be downloaded from our website (see list of Related Resources on this page).