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

May 11, 2020 updated by: NYU Langone Health

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 Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop-University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Preterm delivery (< 37 weeks)
Term delivery (>=37 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preterm delivery
Time Frame: Course of pregnancy
Course of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101436-3
  • 07009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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