CellulaR Injury and Preterm Birth



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 45
Updated:9/22/2018
Start Date:January 2015
End Date:August 2020
Contact:Valerie Armendariz, MS
Email:valerie.armendariz@uphs.upenn.edu
Phone:215-615-6047

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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.

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.

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
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Michal A Elovitz, MD
Phone: 215-615-6047
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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mi
from
Philadelphia, PA
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