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

5. desember 2017 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

2

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29605
        • Greenville Hospital System University Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Forventningsfull ledelse
Forsøkspersonene vil få PPUL administrert forventningsfullt ved hjelp av serum-hCG-overvåking.
Annen: Expectant Management
Pregnancy will be expectantly managed using serum hcg monitoring.
Aktiv komparator: Empirisk behandling med MTX for alle
Pasienter vil bli behandlet med metotreksat, og får én dose på dag 0 og en påfølgende dose på dag 4. Ytterligere doser vil bli administrert etter behov basert på hCG-nivåer.
Legemiddel: Metotreksat
Todoseprotokoll: Pasienten vil motta den første dosen MTX 50mg/m2 på behandlingsdag 0. Hun vil motta en andre dose MTX 50 mg/m2 på behandlingsdag 4 og et serum-hCG-nivå vil bli tatt. Påfølgende doser av MTX vil bli administrert basert på hCG-nivåer.
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.
Legemiddel: Metotreksat
Todoseprotokoll: Pasienten vil motta den første dosen MTX 50mg/m2 på behandlingsdag 0. Hun vil motta en andre dose MTX 50 mg/m2 på behandlingsdag 4 og et serum-hCG-nivå vil bli tatt. Påfølgende doser av MTX vil bli administrert basert på hCG-nivåer.
Fremgangsmåte: Uterin Evakuering
Uterin evakuering eller dilatasjon og curettage. Etter klinikerens skjønn kan dette utføres ved bruk av lokalbedøvelse, sedasjon eller generell anestesi og kan bruke en manuell eller elektrisk evakuering.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Pennsylvania

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2013

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

25. februar 2013

Først innsendt som oppfylte QC-kriteriene

25. februar 2013

Først lagt ut (Anslag)

27. februar 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. desember 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. desember 2017

Sist bekreftet

1. desember 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 815013

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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