Protein and Ultrasound Indicators of Preterm Birth
22 avril 2016 mis à jour par: University of Colorado, Denver
Women are being asked to participate in a research study that is looking for new methods to understand and predict premature birth (birth before 37 weeks of pregnancy-full term pregnancy is 40 weeks).
In this study the investigators will be looking at proteins in vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and stiffness, in order to try to know who will have a preterm birth and who will reach full term.
The investigators will collect the vaginal fluid samples and perform ultrasounds both in the clinic throughout pregnancy in normal women, and from women admitted to the hospital because they are in early labor.
The investigators will collect the placental tissue after the baby is born (this is normally discarded).
This study will help us to understand the process of preterm birth and the investigators hope that this will eventually allow us to develop better methods to treat preterm labor and prevent the birth of premature babies.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Colorado
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Denver, Colorado, États-Unis, 80045
- University Of Colorado Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
14 ans à 45 ans (Enfant, Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Pregnant women with a single intrauterine pregnancy with good gestational age dating, and live fetus with no indications for preterm delivery will be enrolled.
Three groups of subjects will be recruited: a) 50 women with uncomplicated pregnancies and no history of preterm birth, b) 50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM) c) 20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth.
Pregnant women of all races and ethnicities will be recruited into the study.
La description
Inclusion Criteria:
- Single live intrauterine pregnancy
- Good gestational age dating
Exclusion Criteria:
- History of prior cervical procedure such as LEEP, CKC, or cryotherapy
- Maternal or fetal indication for preterm delivery
- Cerclage in place
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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1) Pregnant women with a single intrauterine pregnancy
50 women with uncomplicated pregnancies and no history of preterm birth.
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2) Pregnant women with a single intrauterine pregnancy
50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM).
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3) Pregnant women with a single intrauterine pregnancy
20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Changes in Serial Elastography Measurements
Délai: Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
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Serial elastography measurements will enable us to quantify changes in tissue modulus and structure longitudinally through normal, term pregnancy.
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Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Biomechanical and biochemical analyses of the chorioamnion
Délai: Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
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To quantify the strength and related mechanical properties, characterize the composition of the extracellular matrix, and characterize the secreted protein profile.
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Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
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Correlation of Protein and biochemical analysis of the cervicovaginal fluid (CVF)
Délai: Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
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Protein and biochemical analysis of the CVF, and correlation with cervical tissue stiffness and morphology, will enable detection of specific bio-markers that are present during normal and premature cervical ripening.
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Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
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Stratification of Ultrasound parameters, chorioamnion biomechanical and biochemical properties, and CVF proteins .
Délai: Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
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Identify specific values and biomarkers able to identify patients at risk of preterm labor and preterm birth.
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Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Virginia Ferguson, PhD, University of Colorado, Boulder
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2011
Achèvement primaire (Réel)
1 décembre 2013
Achèvement de l'étude (Réel)
1 décembre 2013
Dates d'inscription aux études
Première soumission
8 août 2011
Première soumission répondant aux critères de contrôle qualité
8 août 2011
Première publication (Estimation)
9 août 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
26 avril 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 avril 2016
Dernière vérification
1 avril 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 11-0570
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