View Clinical Trial (Medical Research Study)
Non-Invasive Biomarkers To Identify Subjects At Risks For Preterm Delivery
| City: |
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Mineola |
| State: |
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New York |
| Zip Code: |
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11501 |
| Conditions: |
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Preterm Birth |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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Inclusion Criteria:
- Women with a diagnosis of preterm labor.
Exclusion Criteria:
- Multiple pregnancy, fetal anomalies, abruptio placenta, preeclampsia, cervical
dilation greater than 4 cm, clinical signs of infection and vaginal bleeding
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| NCT ID: |
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NCT00919412 |
| Primary Contact: |
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Principal Investigator
Graham G Ashmead, MD
Winthrop University Hospital
Graham G Ashmead, MD
Phone: 516-663-8661
Email: gashmead@winthrop.org
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| Backup Contact: |
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Email: jfarrell@winthrop.org
Jean Farrell, RN
Phone: 516-663-2602
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| Location Contact: |
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Mineola, New York 11501
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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