NCT04160221|Completed
Second Trimester Medical Abortion
RAPM
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RAPM
Sponsor study identifier
interventional
80
1 country
1
Study Start
November 1, 2019
Actual (reported)Primary Completion
October 1, 2024
Actual (reported)Study Completion
October 1, 2024
Actual (reported)The use of Mifepristone, an antiprogesterone, and Misoprostol together, has been shown to make the medial abortion process more efficient and reduce the induction-to-abortion interval by almost 50%. Despite the recommended 24-48 Mifepristone-Misoprostol interval, recent retrospective study of a flexible interval, have revealed shorter total abortion time with shorter intervals. In this study we aim to compare 24 to 12 hours Mifepristone to Misoprostol intervals
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2019
Actual (reported)November 6, 2019
Actual (reported)November 12, 2019
Actual (reported)October 1, 2024
Actual (reported)October 1, 2024
Actual (reported)Induction-abortion time
Total induction to complete abortion ( estimated by hours)
Through completion of abortion, an estimated period of up to 3 days
Fever
From the beginning until completion of abortion,estimated up to two weeks
Excessive blood loss
From the beginning until completion of abortion, estimated up to two weeks
Any emergency department visit
From the beginning until completion of abortion, estimated up to two weeks
Mifepristone followed by Misoprostol treatment
Mifepristone followed by Misoprostol treatment
Time interval between treatments
Time interval between treatments
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sheba Medical Center
Ramat Gan, 56506, Israel
Lohr PA, Hayes JL, Gemzell-Danielsson K. Surgical versus medical methods for second trimester induced abortion. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006714. doi: 10.1002/14651858.CD006714.pub2.
ACOG Practice Bulletin No. 135: Second-trimester abortion. Obstet Gynecol. 2013 Jun;121(6):1394-1406. doi: 10.1097/01.AOG.0000431056.79334.cc. No abstract available.
Borgatta L, Kapp N; Society of Family Planning. Clinical guidelines. Labor induction abortion in the second trimester. Contraception. 2011 Jul;84(1):4-18. doi: 10.1016/j.contraception.2011.02.005. Epub 2011 Mar 30.
Aya A Mohr-Sasson, M.D
Sheba Medical Center
80 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2019
First Posted
November 12, 2019
Study Start
November 1, 2019
Actual (reported)Contact the study team to confirm eligibility.
Costescu D, Guilbert E. No. 360-Induced Abortion: Surgical Abortion and Second Trimester Medical Methods. J Obstet Gynaecol Can. 2018 Jun;40(6):750-783. doi: 10.1016/j.jogc.2017.12.010.
Li HWR, Gemzell-Danielsson K. Mechanisms of action of emergency contraception pills. Eur J Contracept Reprod Health Care. 2019 Feb;24(1):11-12. doi: 10.1080/13625187.2018.1555663. Epub 2019 Jan 21. No abstract available.
Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.
Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003 Nov;68(10-13):1013-7. doi: 10.1016/s0039-128x(03)00118-1.
Meyer R, Toussia-Cohen S, Shats M, Segal O, Mohr-Sasson A, Peretz-Bookstein S, Amitai-Komem D, Sindel O, Levin G, Mashiach R, Blumenthal PD. 24-Hour Compared With 12-Hour Mifepristone-Misoprostol Interval for Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2024 Jul 1;144(1):60-67. doi: 10.1097/AOG.0000000000005535. Epub 2024 May 23.
Primary Completion
October 1, 2024
Actual (reported)Study Completion
October 1, 2024
Actual (reported)Last Updated
November 14, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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