CellulaR Injury and Preterm Birth

Preterm Birth Clinical Trial

— CRIB  

Official title:

CellulaR Injury and Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441335
• Other study ID #: 821376
• Status: Completed
• Start date: January 2015
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 705
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	March of Dimes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biogenetics	The role of biogenetics in pregnancy and what are the perturbations in cell metabolism that lead to spontaneous preterm birth.	5 years
Primary	Microbiome	The interactions between the microbiome (oral, gut, cervicovaginal, and placental) and host metabolic function in pregnancy.	5 years
Primary	Cervical remodeling	How the interactions between cell metabolism and the microbiome influence cervical remodeling and placental function leading to spontaneous preterm delivery.	5 years
Primary	Genetics and Environmental factors	How genetic and environmental factors influence the metabolic function of reproductive tissues leading to spontaneous preterm delivery.	5 years