Sulprostone reduces the need for the manual removal of the placenta in patients with retained placenta: A randomized controlled trial Heleen J. van Beekhuizen, MD, a Akosua N. J. A. de Groot, MD, PhD, b Theo De Boo, MS, b David Burger, PhD, b Nicoline Jansen, MD, b Fred K. Lotgering, MD, PhD b, * Jeroen Bosch Hospital, s-Hertogenbosch, The Netherlands a ; Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands b Received for publication April 19, 2005; revised July 23, 2005; accepted August 11, 2005 KEY WORDS Retained placenta Postpartum hemorrhage Sulprostone Manual removal of placenta Objective: The purpose of this study was to determine the extent that the administration of sulprostone reduces the need for manual removal of the placenta in patients with retained placenta. Study design: A double-blinded sequential randomized controlled trial of sulprostone versus placebo was conducted among 103 patients with retained placenta. Results: In the first phase of this sequential study, sulprostone was compared with placebo. The null hypothesis of equal effectiveness of both treatments was rejected after 50 patients. In patients with retained placenta, the placenta was expelled after sulprostone in 13 of 24 cases (51.8%, bias adjusted), whereas expulsion after placebo was achieved in only 4 of 26 cases (17.6%, bias adjusted). The difference was significant (P = .034). In the second phase of the study, in which the placebo arm was stopped, results were confirmed; in 25 of 53 patients (47%), the placenta was expelled. Conclusion: Sulprostone reduces the need for the manual removal of the placenta by 49%. Ó 2006 Mosby, Inc. All rights reserved. Retained placenta (RP) is a common cause of post- partum hemorrhage and maternal death worldwide. 1 The definition of RP varies among different countries. In The Netherlands, the diagnosis RP is made if the placenta has not been expelled within 60 minutes after the delivery of the infant. The incidence of a RP depends on the length of time after which RP is defined and the occurrence of risk factors such as premature labor and a history of RP. In an unselected cohort of 3464 nulliparous women, the incidence of RP after 60 minutes was 1.8%. 2 The usual treatment of RP, manual removal of the placenta (MRP), is performed with the use of general or spinal anaesthesia. 3 Alternative nonoperative methods, such as the umbilical vein injection of saline solution plus oxytocin or prostaglandin, to achieve expulsion of the placenta * Reprint requests: Fred K. Lotgering, MD, PhD, Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Office code 415, PO Box 9101, 6500 HB Nijmegen, The Netherlands. E-mail: f.lotgering@obgyn.umcn.nl 0002-9378/$ - see front matter Ó 2006 Mosby, Inc. All rights reserved. doi:10.1016/j.ajog.2005.08.029 American Journal of Obstetrics and Gynecology (2006) 194, 446–50 www.ajog.org