CellulaR Injury and Preterm Birth

Completed

• Conditions: Preterm Birth

• Registration Number: NCT02441335
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 705

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States