- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02178878
Genetic and Demographic Factors That Influence the Pain and Progress of Labor
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
Virginia
-
Charlottesville, Virginia, États-Unis, 22908
- Recrutement
- University of Virginia
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Sous-enquêteur:
- Abdullah S Terkawi, M.D.
-
Contact:
- Abdullah S Terkawi, MD
-
Charlottesville, Virginia, États-Unis, 22903
- Pas encore de recrutement
- University of Virginia
-
Contact:
- Abdullah S Terkawi, M.D.
- Numéro de téléphone: 434-242-3145
- E-mail: asterkawi@virginia.edu
-
Contact:
- Marcia Birk
- E-mail: meb2w@virginia.edu
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Sous-enquêteur:
- Abdullah S Terkawi, M.D.
-
Chercheur principal:
- Marcel E Durieux, M.D., Ph.D
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Progress, Pain
|
Progress, Pain
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Labor progress variability
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Respond variability to different induction, augmentation and pain management medication Prostaglandine, Oxytocin, Epidural analgesia
Délai: admission to hospital discharge ( est. 2-3 days)
|
admission to hospital discharge ( est. 2-3 days)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Abdullah S Terkawi, M.D., University of Virginia
- Chercheur principal: Marcel E Durieux, M.D., Ph.D, University of Virginia
- Chercheur principal: Pamela D Flood, M.D., Ph.D, Stanford University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 17054
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