Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
In Mexico City, the registration of a new mifepristone product signals a new wave in the SSDF's program for terminating pregnancies up to 70 days. This study evaluates the efficacy of the product Zacafemyl for the termination of pregnancy up to 70 days LMP. It also evaluates the incidence and acceptability of side effects of the medication and regimen. Participants are women of reproductive age with a gestational age of less than or equal to 70 days who want and are eligible for medical abortion, are willing and able to provide all follow up information, and have no contraindications.
Women who are eligible and consent to enroll in the study will be given 200 mg of mifepristone orally in the clinic. The participants will then be given 800 mcg of misoprostol (four 200 mcg tablets) to take home and instructed to take two tablets bucally 24-48 hours after the mifepristone and the remaining tablets within 30 minutes. They will be warned of the side effects they may experience.
All participants will be informed that they can call the clinic in case they have questions about the symptoms or side effects or if they have other concerns. They will also be told that they can return to the clinic in case of severe or persistent bleeding, or if they decide at any point that they want surgical intervention. Participants will also be informed as to the signs of pregnancy termination.
Seven days after taking the mifepristone (the eighth day of the study) the woman should return to the clinic for follow up. Information will be collected on a series of six semi-structured forms that are filled out by members of the study team in accordance with the responses of the participants to the interview questions and the results of physical exams, ultrasounds, etc. Analyses of the data will focus on efficacy, acceptability, side effects, and adverse events.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10010
- Gynuity Health Projects
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Women of reproductive age
- Gestational age less than or equal to 70 days LMP
- Willing and capable of accepting and participating
- Eligible for medical abortion according to the clinic's evaluation
- Willing to undergo a surgical intervention to complete the abortion if necessary
- Willing to provide an address and/or telephone number for follow up
- Have easy, straightforward access to a telephone and emergency transport
Exclusion Criteria:
- Gestational age is greater than 70 days LMP
- Suspicion or diagnosis of ectopic pregnancy or undiagnosed adnexal mass
- Use of IUD (note: the woman will be eligible when she removes the IUD)
- Chronic renal failure
- Current long term treatment with corticosteroids
- Allergy to mifepristone, misoprostol, or other prostaglandin
- Coagulopathies or current treatment with anti-coagulants
- Hereditary porphyrias
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Study population
All study participants will receive 200 mg of the mifepristone product "Zacafemyl", followed 24-48 hours later by 800 mcg of misoprostol.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Efficacy
Lasso di tempo: One week after enrollment
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Was the method effective in terminating pregnancy?
This will be determined by the need for surgical intervention and the dose of misoprostol required.
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One week after enrollment
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Acceptability
Lasso di tempo: One week after enrollment
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Was the method acceptable from the perspective of the woman?
Were the side effects acceptable to women?
Was the buccal route acceptable to women?
Responses will be marked as "very satisfied", "satisfied", "neither satisfied nor unsatisfied", "unsatisfied", or "very unsatisfied".
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One week after enrollment
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Beverly Winikoff, MD, Gynuity Health Projects
- Investigatore principale: Patricio Sanhueza Smith, Secretaria de Salud, Mexico
- Investigatore principale: Maria Laura Garcia, M.I. Inguaran
- Investigatore principale: Ana Gabriela Arangure Peraza, C.S. Beatriz Velasco
Pubblicazioni e link utili
Pubblicazioni generali
- Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4.
- Gouk EV, Lincoln K, Khair A, Haslock J, Knight J, Cruickshank DJ. Medical termination of pregnancy at 63 to 83 days gestation. Br J Obstet Gynaecol. 1999 Jun;106(6):535-9. doi: 10.1111/j.1471-0528.1999.tb08320.x.
- Hamoda H, Ashok PW, Flett GM, Templeton A. Medical abortion at 9-13 weeks' gestation: a review of 1076 consecutive cases. Contraception. 2005 May;71(5):327-32. doi: 10.1016/j.contraception.2004.10.015.
- Hamoda H, Ashok PW, Flett GM, Templeton A. A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation. BJOG. 2005 Aug;112(8):1102-8. doi: 10.1111/j.1471-0528.2005.00638.x.
- Grupo de Informacion en Reproduccion Elegida (GIRE). El aborto en los codigos penales de las entidades federativas. Citacion obtenida por Internet el 8 de octubre de 2007. http://www.gire.org.mx/contenido.php?informacion=31
- Bracken H, Ngoc NT, Schaff E, Coyaji K, Ambardekar S, Westheimer E, Winikoff B. Mifepristone followed in 24 hours to 48 hours by misoprostol for late first-trimester abortion. Obstet Gynecol. 2007 Apr;109(4):895-901. doi: 10.1097/01.AOG.0000259319.18958.76.
- Ashok PW, Hamoda H, Flett GM, Kidd A, Fitzmaurice A, Templeton A. Patient preference in a randomized study comparing medical and surgical abortion at 10-13 weeks gestation. Contraception. 2005 Feb;71(2):143-8. doi: 10.1016/j.contraception.2004.08.013.
- Ashok PW, Kidd A, Flett GM, Fitzmaurice A, Graham W, Templeton A. A randomized comparison of medical abortion and surgical vacuum aspiration at 10-13 weeks gestation. Hum Reprod. 2002 Jan;17(1):92-8. doi: 10.1093/humrep/17.1.92.
- Hamoda H, Ashok PW, Flett GM, Templeton A. A randomized trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion at 13-20 weeks gestation. Hum Reprod. 2005 Aug;20(8):2348-54. doi: 10.1093/humrep/dei037. Epub 2005 May 5.
- Datos no publicados. Comunicacion personal I. Dzuba, Gynuity Health Projects, 22 de junio del 2011.
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Completamento primario (Effettivo)
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Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 1002
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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