Protein and Ultrasound Indicators of Preterm Birth
22 de abril de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Colorado
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Denver, Colorado, Estados Unidos, 80045
- University of Colorado Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
14 años a 45 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Serial Elastography Measurements
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Biomechanical and biochemical analyses of the chorioamnion
Periodo de tiempo: 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)
Periodo de tiempo: 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 .
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Virginia Ferguson, PhD, University of Colorado, Boulder
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2011
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
8 de agosto de 2011
Primero enviado que cumplió con los criterios de control de calidad
8 de agosto de 2011
Publicado por primera vez (Estimar)
9 de agosto de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2016
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11-0570
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