- ICH GCP
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- Klinische proef NCT02178878
Genetic and Demographic Factors That Influence the Pain and Progress of Labor
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22908
- Werving
- University of Virginia
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Onderonderzoeker:
- Abdullah S Terkawi, M.D.
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Contact:
- Abdullah S Terkawi, MD
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Charlottesville, Virginia, Verenigde Staten, 22903
- Nog niet aan het werven
- University of Virginia
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Contact:
- Abdullah S Terkawi, M.D.
- Telefoonnummer: 434-242-3145
- E-mail: asterkawi@virginia.edu
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Contact:
- Marcia Birk
- E-mail: meb2w@virginia.edu
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Onderonderzoeker:
- Abdullah S Terkawi, M.D.
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Hoofdonderzoeker:
- Marcel E Durieux, M.D., Ph.D
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
Progress, Pain
|
Progress, Pain
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Labor progress variability
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Respond variability to different induction, augmentation and pain management medication Prostaglandine, Oxytocin, Epidural analgesia
Tijdsspanne: admission to hospital discharge ( est. 2-3 days)
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admission to hospital discharge ( est. 2-3 days)
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Abdullah S Terkawi, M.D., University of Virginia
- Hoofdonderzoeker: Marcel E Durieux, M.D., Ph.D, University of Virginia
- Hoofdonderzoeker: Pamela D Flood, M.D., Ph.D, Stanford University
Publicaties en nuttige links
Algemene publicaties
- Terkawi AS, Jackson WM, Thiet MP, Hansoti S, Tabassum R, Flood P. Oxytocin and catechol-O-methyltransferase receptor genotype predict the length of the first stage of labor. Am J Obstet Gynecol. 2012 Sep;207(3):184.e1-8. doi: 10.1016/j.ajog.2012.06.079. Epub 2012 Jul 10.
- Terkawi AS, Jackson WM, Hansoti S, Tabassum R, Flood P. Polymorphism in the ADRB2 gene explains a small portion of intersubject variability in pain relative to cervical dilation in the first stage of labor. Anesthesiology. 2014 Jul;121(1):140-8. doi: 10.1097/ALN.0000000000000258.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 17054
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