- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02441335
CellulaR Injury and Preterm Birth (CRIB)
2 de octubre de 2019 actualizado por: University of Pennsylvania
The goal of this study is to examine how cellular dysfunction can lead to preterm birth.
Women with singleton pregnancies with spontaneous preterm labor, preterm premature rupture of membranes, and cervical insufficiency (20 to 36-6/7 weeks gestation), and term deliveries (greater than 38 weeks) will be enrolled.
Medical/obstetric history and pregnancy outcomes will be recorded.
Maternal blood, urine and cervical cells (enrollment); cord blood and placental biopsy (delivery) will be collected.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Despite improvements in prenatal care, preterm birth (PTB) remains a leading contributor to perinatal morbidity and mortality.
Several genetic and environmental factors have been associated with spontaneous preterm birth, but the pathways by which these factors induce preterm delivery have not been defined.
The March of Dimes CPR at the University of Pennsylvania was created to help elucidate the pathogenesis of preterm birth by bringing together a diverse team of investigators with expertise in preterm birth, cellular metabolism, genetics, mitochondrial functional analyses, genome, epigenome, and transcriptome profiling, integrated bioinformatics analyses, and microbiome research.
The center will focus on addressing the interactions between bioenergetics, genetics, microbiome, abnormal cervical remodeling and placental dysfunction.
Each one of these factors will be studied independently and in relation to the other factors.
In order to study metabolic processes in relation to spontaneous PTB, a prospective case-control study will be performed.
This study will involve women with singleton pregnancies with spontaneous preterm labor (PTL), preterm premature rupture of membranes (PPROM), and cervical insufficiency, between 20-0/7 and 36-6/7 weeks gestational age (cases), and women with term deliveries (38 to 41 weeks gestation, controls).
The investigators will obtain information regarding the patients' pertinent past medical and obstetric histories, and the following specimens will be collected: maternal blood, maternal urine, and cervical epithelial cells at enrollment; and umbilical cord blood and placental biopsies at delivery.
We will follow and record each of these patients' pregnancy outcomes.
Tipo de estudio
De observación
Inscripción (Actual)
705
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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Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Hospital of the University of Pennsylvania
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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
18 años a 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
At HUP, there are approximately 4,200 deliveries a year, of which approximately 10 percent (420) deliver preterm.
Among these preterm births, two-thirds (280) are spontaneous, which is the focus of our research.
Many women who ultimately have a preterm birth, first present with preterm labor.
Women who have advanced dilatation, preterm rupture of membranes, etc are at high risk for having a preterm birth.
The investigators anticipate, based on the number of spontaneous preterm births at HUP per year, enrolling about 40-50% of those eligible and understanding that about 40% of those enrolled will have a preterm birth, we should be able to enroll about 112 women per year over 5 years.
The coordinators will enroll cases who are admitted to the hospital with PTL, PPROM, or cervical insufficiency at 20-0/7 to 36-6/7 weeks.
Descripción
Cases:
Inclusion Criteria:
- 18-45 years of age
- Singleton pregnancy between 20 0/7 and 36 6/7 weeks gestational age who is admitted with preterm labor or cervical insufficiency (greater than 2 cm dilation) or Preterm Premature Rupture of Membranes
Exclusion Criteria:
- Multiple gestation
- Fetal chromosomal abnormality
- Major fetal anomaly
- Intra-uterine fetal demise
- Gestational hypertension/preeclampsia
Controls:
Inclusion Criteria:
- 18-45 years of age
- Singleton pregnancy that delivers at term (38 to 41 weeks gestational age)
- Admitted to the hospital with spontaneous labor (regular contractions, cervical dilation) or spontaneous rupture of membranes
Exclusion Criteria:
- Multiple gestation
- Fetal chromosomal abnormality
- Major fetal anomaly
- Intra-uterine fetal demise
- Intra-uterine growth restriction
- Gestational hypertension/preeclampsia
- Clinical chorioaminionitis
- Induction of labor
- Elective c-section
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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Group 1 (Preterm labor, PPROM, cervical insufficiency)
Singleton pregnancy between 20 0/7 36 6/7 weeks gestational age who is admitted with PTL or cervical insufficiency (Equal or greater than 2 cm dilated) or PPROM
|
Group 2 (Term labor)
Admitted to the hospital with spontaneous labor (regular contractions, cervical dilation) or spontaneous rupture of membranes
|
Group 3 (PTB-medically indicated)
Singleton pregnancy between 20 0/7 34 5/6 weeks gestational age who is admitted with a medically indicated preterm birth (IOL for abruption, non reassuring fetal heart tones, intrauterine growth restriction, preeclampsia, trauma, etc.)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Biogenetics
Periodo de tiempo: 5 years
|
The role of biogenetics in pregnancy and what are the perturbations in cell metabolism that lead to spontaneous preterm birth.
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5 years
|
Microbiome
Periodo de tiempo: 5 years
|
The interactions between the microbiome (oral, gut, cervicovaginal, and placental) and host metabolic function in pregnancy.
|
5 years
|
Cervical remodeling
Periodo de tiempo: 5 years
|
How the interactions between cell metabolism and the microbiome influence cervical remodeling and placental function leading to spontaneous preterm delivery.
|
5 years
|
Genetics and Environmental factors
Periodo de tiempo: 5 years
|
How genetic and environmental factors influence the metabolic function of reproductive tissues leading to spontaneous preterm delivery.
|
5 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michal Elovitz, MD, University of Pennsylvania
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 (Actual)
1 de enero de 2015
Finalización primaria (Actual)
1 de agosto de 2019
Finalización del estudio (Actual)
1 de agosto de 2019
Fechas de registro del estudio
Enviado por primera vez
6 de abril de 2015
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2015
Publicado por primera vez (Estimar)
12 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
2 de octubre de 2019
Última verificación
1 de octubre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 821376
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .