NCT00919412

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

3.3 years

First QC Date

June 11, 2009

Last Update Submit

May 11, 2020

Conditions

Preterm Birth

Keywords

Non Invasive Biomarkers Preterm Delivery

Outcome Measures

Primary Outcomes (1)

  • Preterm delivery

    Course of pregnancy

Study Arms (2)

Preterm delivery (< 37 weeks)

Term delivery (>=37 weeks)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Women with a diagnosis of preterm labor.

You may not qualify if:

  • Multiple pregnancy, fetal anomalies, abruptio placenta, preeclampsia, cervical dilation greater than 4 cm, clinical signs of infection and vaginal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop-University Hospital

Mineola, New York, 11501, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood Maternal cervical secretions Fetal umbilical cord blood Placenta

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Graham G Ashmead, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 12, 2009

Study Start

June 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations

US(1)