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Foley Labor Induction Trial at Term and in PROM

9. juni 2017 opdateret af: Angela Bianco, Icahn School of Medicine at Mount Sinai

A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin

This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.

Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.

After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

312

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • New York
      • Elmhurst, New York, Forenede Stater, 11373
        • Elmhurst Hospital Center
      • New York, New York, Forenede Stater, 10029
        • Icahn School of Medicine at Mount Sinai

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

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • women at > 24 weeks gestation
  • a non-anomalous, singleton fetus in a vertex presentation

Exclusion Criteria:

  • history of prior uterine surgery such as cesarean section or myomectomy
  • unexplained vaginal bleeding
  • latex allergy
  • contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)

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
Ingen indgriben: Control
No oxytocin while the Foley bulb is in place
Eksperimentel: Oxytocin
Use of oxytocin while the Foley bulb is in place
Medicin: Oxytocin
Use of oxytocin while the Foley bulb is in place
Andre navne:
  • Pitocin
Eksperimentel: PROMS Foley and oxytocin
Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed.
Medicin: Oxytocin
Use of oxytocin while the Foley bulb is in place
Andre navne:
  • Pitocin
Ingen indgriben: PROMS no Foley bulb
Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
induction time to delivery
Tidsramme: Time from induction to delivery, average 12-28 hours
The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.
Time from induction to delivery, average 12-28 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mode of delivery
Tidsramme: average of 12-28 hours from induction until official time of birth
The mode of delivery is ascertained from the delivery summary as either spontaneous vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, or forcep assisted vaginal delivery.
average of 12-28 hours from induction until official time of birth
estimated blood loss
Tidsramme: average of 12-28 hours from induction until official time of birth
average of 12-28 hours from induction until official time of birth
uterine atony
Tidsramme: average of 12-28 hours from induction until official time of birth
uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart.
average of 12-28 hours from induction until official time of birth
chorioamnionitis
Tidsramme: average of 12-28 hours from induction until official time of birth
Chorioamnionitis is ascertained from provider report as fever with either maternal/fetal tachycardia, fundal tenderness, or foul smelling fluid while the patient is in labor.
average of 12-28 hours from induction until official time of birth
neonatal birthweight
Tidsramme: average of 12-28 hours from induction until official time of birth
average of 12-28 hours from induction until official time of birth

Samarbejdspartnere og efterforskere

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

Sponsor

Icahn School of Medicine at Mount Sinai

Efterforskere

  • Ledende efterforsker: Angela Bianco, MD, Icahn School of Medicine at Mount Sinai

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. november 2014

Primær færdiggørelse (Faktiske)

18. april 2016

Studieafslutning (Faktiske)

18. april 2016

Datoer for studieregistrering

Først indsendt

13. marts 2014

Først indsendt, der opfyldte QC-kriterier

24. marts 2014

Først opslået (Skøn)

28. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GCO 13-1279

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Indledning af arbejdskraft

Kliniske forsøg med Oxytocin

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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