Preterm Birth Clinical Trial
Official title:
Non-Invasive Biomarkers To Identify Subjects At Risks For Preterm Delivery
The goal of this study is to identify a non-invasive predictor or predictors that will
increase the clinician's ability to identify patients with preterm labor (PTL) at risk for
preterm delivery (PTD). Through these studies we also hope to reveal potential therapeutic
targets in the prevention of prevention of preterm births.
The study hypothesis is that we can identify non-invasive predictors of PTL at risk for PTD.
STUDY DESIGN This is a prospective study involving a cohort of pregnant subjects with
pre-term labor. Maternal blood and cervical/vaginal fluid will be collected from consenting
subjects with preterm labor. Repeat sampling of cervical fluid will occur as often as weekly
until the time of delivery. Relevant clinical and demographic data will be recorded. Levels
of prostaglandins (PG's), lipocalin-type prostaglandin D2 synthase (L-PGDS) and cytokines
will be determined using ELISA. DNA will also be extracted from maternal blood for SNP
analysis of cytokine genes. At the time of delivery, cord blood and placenta samples will be
collected if logistically possible (during regular laboratory hours). To determine fetal
levels of PG's, L-PGDS and cytokines in cord blood will be analyzed using ELISA. Placental
samples will be used for in vitro studies aimed at investigating the placental regulatory
pathways of cytokine and PG production. Placental samples will also be processed and embedded
in paraffin for use in immunohistochemical studies in order to localize the expression of
PG's and cytokines. Clinical delivery data will also be recorded.
Gender of Subjects. Only female subjects will be included.
Age of Subjects. The age of subjects will be restricted to 18-45 years.
Inclusion Criteria. Women with a diagnosis of preterm labor will be included in this study.
Preterm labor will be diagnosed as
Six or more contractions per hour associated with one of the following:
1. cervical dilation >= 2 cm
2. cervical effacement > 80%
3. documented changes in dilation or effacement
OR Cervical length less than 2.5 cm by ultrasound with or without contractions.
Exclusion Criteria. Multiple pregnancy, fetal anomalies, abruptio placenta, preeclampsia,
cervical dilation greater than 4 cm, clinical signs of infection and vaginal bleeding.
Subject Capacity. All subjects included in this study will have the capacity to give informed
consent.
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