Comparison of the Effectiveness of Treatment With Mifepristone and Misoprostol at the Same Time Compared to the Administration of Drugs at a 48-hour Interval for Medical Abortion.
NCT ID: NCT03440866
Last Updated: 2022-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2018-03-01
2023-12-30
Brief Summary
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This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.
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Detailed Description
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The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. The patients are recommended to have an ultrasound examination after 2 to 3 weeks. There is little data to compare the efficacy of concomitant administration of both drugs according to the dosage of this protocol and different time intervals.
This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.
Participants in the study group will be given both drugs at the same time while participants in the control group will be given Mifepristone and Misoprostol in an interval of 48 hours.
The investigators hypothesis is that administration of both drugs concomitantly will not change significantly the success rate of the procedure and will not enhance the side effects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Administration of drugs concomitantly.
Administration of drugs concomitantly.
Administration of oral Mifepristone 600 mg and oral Misoprostol 400 mcg concomitantly.
Control
Administration of oral Mifepristone 600 mg and after interval of 48 hours administration of oral Misoprostol 400 mcg.
No interventions assigned to this group
Interventions
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Administration of drugs concomitantly.
Administration of oral Mifepristone 600 mg and oral Misoprostol 400 mcg concomitantly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patient who desire to terminate their pregnancy and have approval of the committee for termination of pregnancy
* patient who gave their consent to have a surgical abortion eventual if needed
Exclusion Criteria
* suspected ectopic pregnancy
* systemic treatment with steroids
* adrenal insufficiency
* heart and blood vessels disease
* coagulopathy or use of anti-thrombotic agents
* uncontrolled asthma
* liver or kidney insufficiency
* anorexia
* intrauterine device
* breastfeeding
18 Years
FEMALE
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Principal Investigators
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meirav braverman, MD
Role: PRINCIPAL_INVESTIGATOR
HaEmek Medical Center, Afula, Israel
Locations
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HaEmek medical center
Afula, , Israel
Countries
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References
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Creinin MD, Schreiber CA, Bednarek P, Lintu H, Wagner MS, Meyn LA; Medical Abortion at the Same Time (MAST) Study Trial Group. Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial. Obstet Gynecol. 2007 Apr;109(4):885-94. doi: 10.1097/01.AOG.0000258298.35143.d2.
Termination of pregnancy with reduced doses of mifepristone. World Health Organisation Task Force on Post-ovulatory Methods of Fertility Regulation. BMJ. 1993 Aug 28;307(6903):532-7. doi: 10.1136/bmj.307.6903.532.
McKinley C, Thong KJ, Baird DT. The effect of dose of mifepristone and gestation on the efficacy of medical abortion with mifepristone and misoprostol. Hum Reprod. 1993 Sep;8(9):1502-5. doi: 10.1093/oxfordjournals.humrep.a138287.
Creinin MD, Schwartz JL, Pymar HC, Fink W. Efficacy of mifepristone followed on the same day by misoprostol for early termination of pregnancy: report of a randomised trial. BJOG. 2001 May;108(5):469-73. doi: 10.1111/j.1471-0528.2001.00117.x.
World Health Organisation Task Force on Post-ovulatory Methods of Fertility Regulation; Special Programme of Research, Development and Research Training; World Health Organisation. Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: a randomised trial. BJOG. 2000 Apr;107(4):524-30. doi: 10.1111/j.1471-0528.2000.tb13273.x.
Creinin MD, Fox MC, Teal S, Chen A, Schaff EA, Meyn LA; MOD Study Trial Group. A randomized comparison of misoprostol 6 to 8 hours versus 24 hours after mifepristone for abortion. Obstet Gynecol. 2004 May;103(5 Pt 1):851-9. doi: 10.1097/01.AOG.0000124271.23499.84.
von Hertzen H, Piaggio G, Wojdyla D, Marions L, My Huong NT, Tang OS, Fang AH, Wu SC, Kalmar L, Mittal S, Erdenetungalag R, Horga M, Pretnar-Darovec A, Kapamadzija A, Dickson K, Anh ND, Tai NV, Tuyet HT, Peregoudov A; WHO Research Group on Post-ovulatory Methods of Fertility Regulation. Two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial. BJOG. 2009 Feb;116(3):381-9. doi: 10.1111/j.1471-0528.2008.02034.x.
Garg G, Takkar N, Sehgal A. Buccal versus vaginal misoprostol administration for the induction of first and second trimester abortions. J Obstet Gynaecol India. 2015 Apr;65(2):111-6. doi: 10.1007/s13224-014-0605-5. Epub 2014 Oct 31.
Murthy AS, Creinin MD, Harwood B, Schreiber C. A pilot study of mifepristone and misoprostol administered at the same time for abortion up to 49 days gestation. Contraception. 2005 May;71(5):333-6. doi: 10.1016/j.contraception.2004.10.006.
Goel A, Mittal S, Taneja BK, Singal N, Attri S. Simultaneous administration of mifepristone and misoprostol for early termination of pregnancy: a randomized controlled trial. Arch Gynecol Obstet. 2011 Jun;283(6):1409-13. doi: 10.1007/s00404-011-1881-2. Epub 2011 Mar 23.
Schaff E. Evidence for shortening the time interval of prostaglandin after mifepristone for medical abortion. Contraception. 2006 Jul;74(1):42-4. doi: 10.1016/j.contraception.2006.03.014. Epub 2006 May 12.
Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Contraception. 2001 Aug;64(2):81-5. doi: 10.1016/s0010-7824(01)00229-3.
Wedisinghe L, Elsandabesee D. Flexible mifepristone and misoprostol administration interval for first-trimester medical termination. Contraception. 2010 Apr;81(4):269-74. doi: 10.1016/j.contraception.2009.09.007. Epub 2009 Oct 29.
Other Identifiers
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2-17 EMC
Identifier Type: -
Identifier Source: org_study_id
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