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Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation

17. oktober 2013 opdateret af: Gynuity Health Projects
The purpose of this study is to determine the efficacy and acceptability of a regimen of 200 mg mifepristone (Zacafemyl), followed 24-48 hours later by 800 mcg of buccal misoprostol.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1001

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10010
        • Gynuity Health Projects

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Pregnant women at the study clinics who want medical abortion and meet eligibility criteria.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Study population
All study participants will receive 200 mg of the mifepristone product "Zacafemyl", followed 24-48 hours later by 800 mcg of misoprostol.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy
Tidsramme: One week after enrollment
Was the method effective in terminating pregnancy? This will be determined by the need for surgical intervention and the dose of misoprostol required.
One week after enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptability
Tidsramme: One week after enrollment
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".
One week after enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gynuity Health Projects

Samarbejdspartnere

Secretaria de Salud, Mexico

Efterforskere

  • Ledende efterforsker: Beverly Winikoff, MD, Gynuity Health Projects
  • Ledende efterforsker: Patricio Sanhueza Smith, Secretaria de Salud, Mexico
  • Ledende efterforsker: Maria Laura Garcia, M.I. Inguaran
  • Ledende efterforsker: Ana Gabriela Arangure Peraza, C.S. Beatriz Velasco

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. maj 2012

Datoer for studieregistrering

Først indsendt

16. oktober 2013

Først indsendt, der opfyldte QC-kriterier

17. oktober 2013

Først opslået (Skøn)

22. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1002

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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