MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure

NCT00468299 | Terminated Results DMC

• 1 other identifier: H-25999
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Pregnancy Failure; Miscarriage; Fetal Demise; Anembryonic Pregnancy

Keywords

early; pregnancy; failure; mifepristone; misoprostol; buccal; miscarriage; fetal; demise; anembryonic; progesterone

Outcome Measures

Primary Outcomes (1)

• Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.

  24-48 hrs

Secondary Outcomes (1)

• Complete Abortion at One Week

  3 weeks

Study Arms (2)

Misoprostol and placebo

ACTIVE COMPARATOR

Women in this arm receive placebo and misoprostol 800 mcg buccally

Drug: Misoprostol and placebo

Mifepristone and misoprostol

EXPERIMENTAL

Womwn in this group receive mifepristone 200 mg orally and misoprostol 800 mcg buccally

Drug: Mifepristone and misoprostol

Interventions

Misoprostol and placebo DRUG

Women in this group receive 800 mcg misoprostol plus a placebo

Misoprostol and placebo

Mifepristone and misoprostol DRUG

This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally

Mifepristone and misoprostol

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>18yrs, able to read and write English
• Intrauterine gestations with anembryonic sac between 10 and 45mm or
• mm 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02118, United States

Location

Related Publications (15)

• 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. doi: 10.1093/humrep/deh049.

  PMID: 14747165 BACKGROUND

• Creinin MD, Schwartz JL, Guido RS, Pymar HC. Early pregnancy failure--current management concepts. Obstet Gynecol Surv. 2001 Feb;56(2):105-13. doi: 10.1097/00006254-200102000-00024.

  PMID: 11219590 BACKGROUND

• 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.

  PMID: 7920940 BACKGROUND

• 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. doi: 10.1016/j.ajog.2005.05.010.

  PMID: 16202723 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000230398.32794.9d.

  PMID: 16946218 BACKGROUND

• 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. doi: 10.1016/j.contraception.2005.05.017. Epub 2005 Aug 9.

  PMID: 16246656 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.1997.tb12075.x.

  PMID: 9307543 BACKGROUND

• Schaff EA, DiCenzo R, Fielding SL. Comparison of misoprostol plasma concentrations following buccal and sublingual administration. Contraception. 2005 Jan;71(1):22-5. doi: 10.1016/j.contraception.2004.06.014.

  PMID: 15639067 BACKGROUND

• 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. doi: 10.1016/j.fertnstert.2006.03.032.

  PMID: 17027362 BACKGROUND

• 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. doi: 10.1093/humrep/17.2.332.

  PMID: 11821273 BACKGROUND

• 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. doi: 10.1136/bmj.38828.593125.55. Epub 2006 May 17.

  PMID: 16707509 BACKGROUND

• Wagaarachchi PT, Ashok PW, Smith NC, Templeton A. Medical management of early fetal demise using sublingual misoprostol. BJOG. 2002 Apr;109(4):462-5. doi: 10.1111/j.1471-0528.2002.01075.x.

  PMID: 12013170 BACKGROUND

• 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. doi: 10.1093/humrep/16.9.1849.

  PMID: 11527887 BACKGROUND

• 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. doi: 10.1056/NEJMoa044064.

  PMID: 16120856 BACKGROUND

• 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. doi: 10.1016/S0029-7844(97)00111-7.

  PMID: 9207820 BACKGROUND

MeSH Terms

Conditions

Abortion, Spontaneous; Fetal Death

Interventions

Misoprostol; Mifepristone

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The study was terminated because of poor enrollment. Few eligible women were referred.

Results Point of Contact

• Title: Dr. Sarah Betstadt
• Organization: University of Rochester

sarah_betstadt@urmc.rochester.edu

585-276-5368

Study Officials

• Sarah J Betstadt, MD

  Boston University

  PRINCIPAL INVESTIGATOR

• Olivera Vragovic, MBA

  Boston University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 1, 2007
• First Posted: May 2, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 21, 2011
• Results First Posted: July 21, 2011

Record last verified: 2011-06

Locations

US (1)