- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01491685
Parturient Microcirculation
An Observational Assessment of the Sublingual Microcirculation of Pregnant and Non-pregnant Women (Parturient Microcirculation - Phase 1)
This is an observational study comparing microcirculation of pregnant to non-pregnant women. "Microcirculation" means blood flow to the extremely small blood vessels in one's body. During pregnancy the amount of blood in a woman's body increases. The body responds to this increase by pumping more blood through the heart and narrowing the size of blood vessels.
There are many types of blood vessels that have different roles in the body. Larger blood vessels. Transport blood to and from body organs like the brain and liver. Small vessels (microcirculation)distributes blood to the organ tissues. The microcirculation can change blood flow and blood pressure. Microcirculation is involved in delivering oxygen and nutrients to your body, removing waste products, and regulating body temperature.
The investigators current understanding of the microcirculation in pregnant women is limited. There is a device available that can measure microcirculation. It is known as Sidestream Dark Field (SDF) imaging. It is a special type of camera that captures pictures of the microcirculation. In this study the investigators will compare the microcirculation, as seen with SDF imaging, of pregnant women to non-pregnant women. By improving the investigators understanding of maternal microcirculation the investigators are adding to the knowledge of how the pregnant body works. The investigators hope to then translate this knowledge into further studies to improve maternal and fetal outcomes through prevention and treatment of maternal low blood pressure caused by spinal anesthesia.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The objectives of this observational trial are; to compare the sublingual microcirculation of pregnant subjects to that of comparable non-pregnant volunteers; to evaluate the usefulness of a non-invasive technology, SDF imaging in pregnant and non-pregnant subjects.
By improving our understanding of maternal microcirculation we not only add to the knowledge of maternal physiology, we hope to then translate this knowledge into further studies to improve maternal and fetal clinical outcomes through prevention and treatment of maternal hypotension especially in relation to spinal anesthesia.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Nova Scotia
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Halifax, Nova Scotia, Canada
- IWK Health Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Pregnant group - women with uncomplicated, singleton, at 36 - 40 weeks gestation, non-laboring
Non-Pregnant group - healthy nulliparous female volunteers, matched to pregnant patients for age ± 1 year
La description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I Healthy, ASA II - mild and controlled systemic disease)
- Pregnant: singleton, 36 - 40 weeks EGA, non-labouring
- Non- Pregnant - Healthy female volunteers who have never been pregnant, matched to pregnant patients for age ± 1 year
Exclusion Criteria:
- Obesity (BMI > 35 kg/m2)
- Hypertensive disease (Essential, gestational, or preeclampsia)
- Diabetes Mellitus Type 1
- Cardiovascular disease
- Smoker (1 cigarette or other tobacco product within 12 months)
- Caffeinated (i.e. coffee, tea, energy drink) beverage with 2 hours
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Enceinte
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Non- Pregnant
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Microvascular Flow Index (MFI)
Délai: 1 yr
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The primary outcome is the difference between the MFI of pregnant versus non-pregnant subjects.
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1 yr
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
PVD
Délai: 1 yr
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Perfused vessel density
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1 yr
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PPV
Délai: 1 yr
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Proportion of perfused vessels
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1 yr
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- IWK1007223
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