prolife definition: Mifepristone (Mifeprex) and Misoprostol is a medical abortion procedure used up to the first seven to nine weeks of pregnancy. It is also referred to as RU-486 or the abortion pill. ================ http://clinicaltrials.gov/ct2/show/NCT00468299 MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure This study is currently recruiting participants. Verified by Boston University, January 2008 Sponsored by: Boston University Information provided by: Boston University ClinicalTrials.gov Identifier: NCT00468299 Purpose The purpose of this study is to compare two combinations of drugs (mifepristone and misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy failure. We will compare the two combinations of medications to see which combination makes miscarriage happen faster. We hypothesize that there will be no difference in time to complete miscarriage between the two groups. Condition Intervention Early Pregnancy Failure Miscarriage Fetal Demise Anembryonic Pregnancy Drug: mifepristone Drug: placebo MedlinePlus related topics: Pregnancy Loss ChemIDplus related topics: Progesterone Mifepristone Misoprostol U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study Official Title: Treatment of Early Pregnancy Failure Further study details as provided by Boston University: Primary Outcome Measures: Rate of complete abortion 24-48hrs after receiving medical treatment for early pregnancy failure. [ Time Frame: 24-48 hrs ] [ Designated as safety issue: No ] Secondary Outcome Measures: Secondary outcomes include: rate of complete abortion at one week, time to expulsion of products of conception, correlation of abortion rates to serum progesterone levels and type of pregnancy failure, number of bleeding days and patient satisfaction [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ] Estimated Enrollment: 108 Study Start Date: April 2007 Estimated Study Completion Date: May 2009 Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure) Arms Assigned Interventions 1: Placebo Comparator Drug: placebo this group does not receive mifepristone 2: Experimental Receives mifepristone and misoprostol Drug: mifepristone 200 mg mifepristone given along with 800 mcg misoprostol Detailed Description: The optimal method of treating Early Pregnancy Failure (EPF) is not certain. For many years, surgical management of EPF was the only treatment option. Now there are multiple studies demonstrating the effectiveness of misoprostol for treating EPF. Most of the studies investigating medical treatment of EPF have evaluated efficacy at one week. We have found that many women do not want to wait for one week for an outcome of their medical treatment, and want resolution sooner. This has hampered the widespread utilization of medical therapy in our institution. We propose a regimen of medical treatment for EPF with expeditious follow-up. We want to demonstrate the relative efficacy of two medication regimens for treatment of EPF by performing a randomized trial. One regimen will be 800µg buccal misoprostol alone and the other regimen will be 200mg mifepristone, orally, in addition to 800µg buccal misoprostol, simultaneously. The primary outcome will be complete abortion rates 24hours after medication administration. We hypothesize that mifepristone will not improve complete abortion rates at 24hrs. Secondary outcomes include rates of abortion by medical treatment at one week, the indications for surgical intervention, relationship of progesterone levels and type of pregnancy failure to outcomes in the two groups. Another secondary objective is to assess satisfaction with the treatment process at the conclusion of pregnancy termination, and 3 weeks after the beginning of the process. The majority of studies investigating medical treatment of EPF use vaginal misoprostol, but buccal use is increasing. We will use buccal misoprostol, which is widely used at our institution. We will assess the efficacy of this route of administration as well as assess patient acceptability of this method. Eligibility Ages Eligible for Study: 18 Years to 64 Years Genders Eligible for Study: Female Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Age >18yrs, able to read and write English Intrauterine gestations with anembryonic sac between 10 and 45mm or 10-15mm sac with no growth in three days or other radiologic signs of abnormal pregnancy such as irregular sac or debris within the gestational sac An embryonic pole <30mm with no cardiac activity Exclusion Criteria: Intrauterine gestations with CRL <5mm or >30mm without cardiac activity Incomplete abortion as defined as open cervix and large amount of cramping/bleeding Hemodynamic instability and/or heavy vaginal bleeding Hemoglobin less than or equal to 8 Inability to follow-up (ie, lack of transportation or access to telephone) Bleeding disorder or taking anticoagulants Prior medical or surgical treatment of the current pregnancy Obvious Infection Active Lactation Allergy to mifepristone or misoprostol Chronic corticosteroid use Severe gastrointestinal disease (e.g inflammatory bowel disease, severe gastritis) Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00468299 Contacts Contact: Sarah J Betstadt, MD 617-414-5109 sarah.betstadt@bmc.org Contact: Lynn Borgatta, MD, MPH 617-414-3440 lynn.borgatta@bmc.org Locations United States, Massachusetts Boston University Recruiting Boston, Massachusetts, United States, 02118 Contact: Olivera Vragovic, MBA 617-414-3704 ovragovi@bu.edu Principal Investigator: Sarah J Betstadt, MD Sub-Investigator: Lynn Borgatta, MD, MPH Sub-Investigator: Judith Linden, MD Sub-Investigator: Nilda Moreno, MD Sponsors and Collaborators Boston University Investigators Principal Investigator: Sarah J Betstadt, MD Boston University Study Director: Olivera Vragovic, MBA Boston University More Information Publications: Bagratee JS, Khullar V, Regan L, Moodley J, Kagoro H. A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Hum Reprod. 2004 Feb;19(2):266-71. Creinin MD, Schwartz JL, Guido RS, Pymar HC. Early pregnancy failure--current management concepts. Obstet Gynecol Surv. 2001 Feb;56(2):105-13. Review. Lelaidier C, Saint-Mleux CB, Fernandez H, Bourget P, Frydman R. [Embryo expulsion induction in first trimester miscarriages. Use of mifepristone (RU 486) in a double blind prospective randomized study] Contracept Fertil Sex. 1993 Jun;21(6):505-8. French. Lister MS, Shaffer LE, Bell JG, Lutter KQ, Moorma KH. Randomized, double-blind, placebo-controlled trial of vaginal misoprostol for management of early pregnancy failures. Am J Obstet Gynecol. 2005 Oct;193(4):1338-43. Meckstroth KR, Whitaker AK, Bertisch S, Goldberg AB, Darney PD. Misoprostol administered by epithelial routes: Drug absorption and uterine response. Obstet Gynecol. 2006 Sep;108(3 Pt 1):582-90. Middleton T, Schaff E, Fielding SL, Scahill M, Shannon C, Westheimer E, Wilkinson T, Winikoff B. Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period. Contraception. 2005 Nov;72(5):328-32. Epub 2005 Aug 9. Nielsen S, Hahlin M, Platz-Christensen JJ. Unsuccessful treatment of missed abortion with a combination of an antiprogesterone and a prostaglandin E1 analogue. Br J Obstet Gynaecol. 1997 Sep;104(9):1094-6. Schaff EA, DiCenzo R, Fielding SL. Comparison of misoprostol plasma concentrations following buccal and sublingual administration. Contraception. 2005 Jan;71(1):22-5. Stockheim D, Machtinger R, Wiser A, Dulitzky M, Soriano D, Goldenberg M, Schiff E, Seidman DS. A randomized prospective study of misoprostol or mifepristone followed by misoprostol when needed for the treatment of women with early pregnancy failure. Fertil Steril. 2006 Oct;86(4):956-60. Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002 Feb;17(2):332-6. Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ. 2006 May 27;332(7552):1235-40. Epub 2006 May 17. Wagaarachchi PT, Ashok PW, Smith NC, Templeton A. Medical management of early fetal demise using sublingual misoprostol. BJOG. 2002 Apr;109(4):462-5. Wagaarachchi PT, Ashok PW, Narvekar N, Smith NC, Templeton A. Medical management of early fetal demise using a combination of mifepristone and misoprostol. Hum Reprod. 2001 Sep;16(9):1849-53. Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C, Frederick MM; National Institute of Child Health Human Development (NICHD) Management of Early Pregnancy Failure Trial. A comparison of medical management with misoprostol and surgical management for early pregnancy failure. N Engl J Med. 2005 Aug 25;353(8):761-9. Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997 Jul;90(1):88-92. Responsible Party: Boston University ( Sarah Betstadt, MD ) Study ID Numbers: H-25999 First Received: May 1, 2007 Last Updated: January 11, 2008 ClinicalTrials.gov Identifier: NCT00468299 Health Authority: United States: Institutional Review Board Keywords provided by Boston University: early pregnancy failure mifepristone misoprostol buccal miscarriage fetal demise anembryonic progesterone Study placed in the following topic categories: Pregnancy Complications Progesterone Misoprostol Mifepristone Abortion, Spontaneous Additional relevant MeSH terms: Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Oxytocics Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Gastrointestinal Agents Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Abortifacient Agents, Nonsteroidal Luteolytic Agents Contraceptives, Postcoital Pharmacologic Actions Female Urogenital Diseases and Pregnancy Complications Therapeutic Uses Anti-Ulcer Agents Abortifacient Agents Menstruation-Inducing Agents ClinicalTrials.gov processed this record on February 01, 2008 U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act