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RCT for Women With a Persisting Pregnancy of Unknown Location (PPUL)

5. december 2017 opdateret af: University of Pennsylvania

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location -- a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy

This is a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy) 2) Empiric treatment with MTX for all, and 3) Expectant management. Randomization will be 2:2:1 into these three arms. After randomization, they will be followed and treated clinically as is indicated by the progression of their condition. Primary outcome measures: uneventful decline of hCG to 5 IU/mL. Secondary outcome measures: re-interventions, treatment complications, health-related quality of life, financial costs, future fertility, and patient's preferences.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Hospital System University Medical Center

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Female with a persisting pregnancy of unknown location:

    1. A pregnancy of unknown location is defined as a women with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging (Ultrasound must be performed within 7 days prior to randomization)
    2. Persistence of hCG is defined as 3 serial hCG values over 4-14 days or 2 serial hCG values over 7-14 days, showing less than 30% rise, or less than 30% fall between the first and last value. (This abnormal pattern of serial hCG confirms that the gestation is nonviable.)
  2. Patient is hemodynamically stable, hemoglobin greater than 10 mg/dL,
  3. Greater than or 18 years of age

Exclusion Criteria:

  1. Hemodynamically unstable in need of acute treatment
  2. Most recent hCG greater than 5000 IU/mL
  3. Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion),
  4. Diagnosis of gestational trophoblastic disease,
  5. Subject unwilling or unable to comply with study procedures,
  6. Presence of clinical contraindications for treatment with methotrexate (ACOG guidelines, Appendix B),
  7. Prior medical or surgical management of this gestation.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Forventningsfuld ledelse
Forsøgspersonerne vil få deres PPUL styret forventningsfuldt ved hjælp af serum-hCG-monitorering.
Andet: Expectant Management
Pregnancy will be expectantly managed using serum hcg monitoring.
Aktiv komparator: Empirisk behandling med MTX til alle
Forsøgspersonerne vil blive behandlet med methotrexat, idet de får en dosis på dag 0 og en efterfølgende dosis på dag 4. Yderligere doser vil blive administreret efter behov baseret på hCG-niveauer.
Medicin: Methotrexat
To-dosis-protokol: Patienten vil modtage den første dosis af MTX 50mg/m2 på behandlingsdag 0. Hun vil modtage en anden dosis MTX 50 mg/m2 på behandlingsdag 4, og et serum-hCG-niveau vil blive udtaget. Efterfølgende doser af MTX vil blive administreret baseret på hCG-niveauer.
Aktiv komparator: Uterine evacuation, then MTX for some
Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.
Medicin: Methotrexat
To-dosis-protokol: Patienten vil modtage den første dosis af MTX 50mg/m2 på behandlingsdag 0. Hun vil modtage en anden dosis MTX 50 mg/m2 på behandlingsdag 4, og et serum-hCG-niveau vil blive udtaget. Efterfølgende doser af MTX vil blive administreret baseret på hCG-niveauer.
Procedure: Uterin Evakuering
Uterin evakuering eller udvidelse og curettage. Efter klinikerens skøn kan dette udføres ved hjælp af lokalbedøvelse, sedation eller generel anæstesi og kan bruge en manuel eller elektrisk evakuering.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.
Tidsramme: Outcome will be assessed within 6 weeks of randomization
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
Outcome will be assessed within 6 weeks of randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Ruptured Ectopic Pregnancies in Each Group
Tidsramme: Outcome will be assess within 6 weeks of randomization
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
Outcome will be assess within 6 weeks of randomization
Quantification of Re-interventions Needed to Manage a Woman With a PPUL
Tidsramme: 6 weeks

Outcomes include:

  • number of interventions beyond that of intended initial strategy in each group

    • additional number of MTX injections
    • additional surgical procedures
  • uterine evacuation (or dilation and curettage)
  • laparoscopy
  • laparotomy
6 weeks
Treatment Complications and Adverse Events
Tidsramme: 42 days after the last dose of study medication
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
42 days after the last dose of study medication
Number of Procedures (Lab Tests, Ultrasounds)
Tidsramme: 6 weeks
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
6 weeks
Number of Visits
Tidsramme: 6 weeks
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
6 weeks
Time to Resolution
Tidsramme: 6 weeks
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
6 weeks
Patients' Preferences
Tidsramme: 6 weeks
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
6 weeks
Acceptability
Tidsramme: 6 weeks
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
6 weeks
Future Fertility
Tidsramme: 6 weeks
Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
6 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

University of Pennsylvania

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. februar 2013

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

25. februar 2013

Først indsendt, der opfyldte QC-kriterier

25. februar 2013

Først opslået (Skøn)

27. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 815013

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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