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Non Invasive Biomarkers to Identify Subjects at Risk for Preterm Delivery (PTMARKER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Winthrop University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00919412
First received: June 11, 2009
Last updated: February 18, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition
Preterm Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Biomarkers To Identify Subjects At Risks For Preterm Delivery

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Preterm delivery [ Time Frame: Course of pregnancy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Maternal blood Maternal cervical secretions Fetal umbilical cord blood Placenta


Estimated Enrollment: 200
Study Start Date: June 2007
Estimated Study Completion Date: December 2010
Groups/Cohorts
Preterm delivery (< 37 weeks)
Term delivery (>=37 weeks)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pregnant women ages 18-45 with a diagnosis of preterm labor

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919412

Contacts
Contact: Graham G Ashmead, MD 516-663-8661 gashmead@winthrop.org
Contact: Jean Farrell, RN 516-663-2602 jfarrell@winthrop.org

Locations
United States, New York
Winthrop-University Hospital Recruiting
Mineola, New York, United States, 11501
Principal Investigator: Graham G Ashmead, MD            
Sub-Investigator: Genevieve Sicuranza, MD            
Sub-Investigator: Louis Ragolia, MD            
Sub-Investigator: Jolene Muscat, MD            
Sub-Investigator: Nazeeh Hanna, MD            
Sub-Investigator: Daniel Kiefer, MD            
Sub-Investigator: Padmalatha Gurram, MD            
Sub-Investigator: Wendy Kinzler, MD            
Sub-Investigator: Martin Chavez, MD            
Sub-Investigator: Christopher Wayock, MD            
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Graham G Ashmead, MD Winthrop University Hospital
  More Information

No publications provided

Responsible Party: Graham Gaylord Ashmead, MD, Department of OB/GYN, Winthrop-University Hospital
ClinicalTrials.gov Identifier: NCT00919412     History of Changes
Other Study ID Numbers: 101436-3, 07009
Study First Received: June 11, 2009
Last Updated: February 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Non Invasive Biomarkers Preterm Delivery

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013