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MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure
This study has been terminated.
( poor enrollment )
Study NCT00468299   Information provided by Boston University

First Received on May 1, 2007.   Last Updated on June 23, 2011   History of Changes
Results First Received: April 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Early Pregnancy Failure
Miscarriage
Fetal Demise
Anembryonic Pregnancy
Interventions: Drug: Misoprostol and placebo
Drug: Mifepristone and misoprostol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Misoprostol and Placebo Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
Mifepristone and Misoprostol Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally

Participant Flow:   Overall Study
    Misoprostol and Placebo     Mifepristone and Misoprostol  
STARTED     9     8  
COMPLETED     9     7  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Misoprostol and Placebo Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
Mifepristone and Misoprostol Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally

Baseline Measures
    Misoprostol and Placebo     Mifepristone and Misoprostol     Total  
Number of Participants  
[units: participants]
 		  9     8     17  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     9     8     17  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  28  ± 4     29  ± 4     28  ± 3  
Gender  
[units: participants]
 		     
Female     9     8     17  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     9     8     17  



  Outcome Measures
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1.  Primary:   Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.   [ Time Frame: 24-48 hrs ]
  Show Outcome Measure 1

2.  Secondary:   Complete Abortion at One Week   [ Time Frame: 3 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated because of poor enrollment. Few eligible women were referred.  


Results Point of Contact:  
Name/Title: Dr. Sarah Betstadt
Organization: University of Rochester
phone: 585-276-5368
e-mail: sarah_betstadt@urmc.rochester.edu


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: Sarah Betstadt, MD, University of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT00468299     History of Changes
Other Study ID Numbers: H-25999
Study First Received: May 1, 2007
Results First Received: April 12, 2011
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board





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