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Genetic and Demographic Factors That Influence the Pain and Progress of Labor

27. juni 2014 opdateret af: University of Virginia
The purpose of this study is to try to understand why the experience of labor differs among women. The investigators want to understand why some women have longer or shorter labors and why the amount of pain women experience is different. The investigators hope to be able to consider women more individually in terms of their pain and progress of labor.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

There is enormous variability among women in the progress of normal labor. Labor requires complex integrated interplay between the decidua, uterine cervix and myometrium that can take minutes, days or weeks to occur and is incompletely understood. Understanding the biological variables that underlie differences in labor progress has been hampered by the lack of appropriate models that allow sensitive statistical analysis. Identification of genetic and physiognomic factors that impact normal labor progress will allow for individualization of labor management and better use of societal resources.

Structural models of labor progress were first proposed by Friedman in the 1950s at Columbia University. Aspects of Friedman's model, such as the deceleration phase, have been debated since that time but Friedman's model allowed for identification and quantification of the latent and active phase of labor in populations. These concepts have been modified by the World Health Organization as the WHO Partogram, the use of which has resulted in reduced requirement of oxytocin and reduced incidence of cesarean section.

Dr. Flood's group has developed a continuous bi-exponential model of labor progress and sigmoidal model for labor pain that the investigators have statistically and experimentally validated in several independent databases. The investigators model can be used both prospectively in an individual labor and with large cohorts to identify variables that significantly affect the progress of labor.

The investigators have found in a previous work that parturients who carry G at the 27th amino acid beta-2 adrenergic receptors (β2AR) developed labor pain more rapidly that parturients with the common allele [1]. and the investigators also have found that catechol-O-methyltransferase (COMT) rs4633 genotype TT resulted in a slower latent phase rate, and oxytocin receptor rs53576 genotype GG transitioned to active labor earlier [2].

In this new project, the investigators are planning to use bigger data base, to detect further genes associations, and tested some pharmacogenetic variations that could explain the different response to same medications and doses among patients.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

800

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Rekruttering
        • University of Virginia
        • Underforsker:
          • Abdullah S Terkawi, M.D.
        • Kontakt:
          • Abdullah S Terkawi, MD
      • Charlottesville, Virginia, Forenede Stater, 22903
        • Ikke rekrutterer endnu
        • University of Virginia
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Abdullah S Terkawi, M.D.
        • Ledende efterforsker:
          • Marcel E Durieux, M.D., Ph.D

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 til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Pregnant in active labor

Beskrivelse

Inclusion Criteria:

  • Study participants will be women presenting in term labor.
  • Patients of all ethnicities will be included.
  • All subjects will be greater than or equal to 18 years of age and able to give consent.

Exclusion Criteria:

  • Include preexisting pain syndromes or the regular taking of pain medications.
  • Preterm birth (< 37 weeks) and preeclampsia.
  • Cervical dilatation more than 6 cm

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
Intervention / Behandling
Progress, Pain
Genetisk: Progress, Pain
Progress, Pain

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Labor progress variability
Tidsramme: We will monitor data from the entire period of labor, which may last from 1-30 hours
We will monitor data from the entire period of labor, which may last from 1-30 hours

Sekundære resultatmål

Resultatmål
Tidsramme
Respond variability to different induction, augmentation and pain management medication Prostaglandine, Oxytocin, Epidural analgesia
Tidsramme: admission to hospital discharge ( est. 2-3 days)
admission to hospital discharge ( est. 2-3 days)

Samarbejdspartnere og efterforskere

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

Sponsor

University of Virginia

Samarbejdspartnere

Stanford University

Efterforskere

  • Ledende efterforsker: Abdullah S Terkawi, M.D., University of Virginia
  • Ledende efterforsker: Marcel E Durieux, M.D., Ph.D, University of Virginia
  • Ledende efterforsker: Pamela D Flood, M.D., Ph.D, Stanford University

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. maj 2014

Primær færdiggørelse (Forventet)

1. juni 2016

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

30. april 2014

Først indsendt, der opfyldte QC-kriterier

27. juni 2014

Først opslået (Skøn)

1. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 17054

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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