- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02178878
Genetic and Demographic Factors That Influence the Pain and Progress of Labor
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
Virginia
-
Charlottesville, Virginia, Förenta staterna, 22908
- Rekrytering
- University of Virginia
-
Underutredare:
- Abdullah S Terkawi, M.D.
-
Kontakt:
- Abdullah S Terkawi, MD
-
Charlottesville, Virginia, Förenta staterna, 22903
- Har inte rekryterat ännu
- University of Virginia
-
Kontakt:
- Abdullah S Terkawi, M.D.
- Telefonnummer: 434-242-3145
- E-post: asterkawi@virginia.edu
-
Kontakt:
- Marcia Birk
- E-post: meb2w@virginia.edu
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Underutredare:
- Abdullah S Terkawi, M.D.
-
Huvudutredare:
- Marcel E Durieux, M.D., Ph.D
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Progress, Pain
|
Progress, Pain
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Labor progress variability
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Respond variability to different induction, augmentation and pain management medication Prostaglandine, Oxytocin, Epidural analgesia
Tidsram: admission to hospital discharge ( est. 2-3 days)
|
admission to hospital discharge ( est. 2-3 days)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Abdullah S Terkawi, M.D., University of Virginia
- Huvudutredare: Marcel E Durieux, M.D., Ph.D, University of Virginia
- Huvudutredare: Pamela D Flood, M.D., Ph.D, Stanford University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 17054
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