NCT01348230

Brief Summary

When babies are premature, or born before they are fully developed, they face many different medical problems, some of which are quite devastating, such as cerebral palsy, mental retardation, blindness, deafness, severe intestinal problems, and developmental delays. Unfortunately, in more than half the cases of premature births, there is no procedure or test that an obstetrician can employ to predict if a fetus is at risk for premature birth, especially when the mother is healthy. This study seeks to determine if certain factors found in the urine undergo specific changes that can be used to detect premature births of this type before they happen.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

May 3, 2011

Last Update Submit

April 19, 2017

Conditions

Preterm Birth

Keywords

Premature prolonged rupture of membranesPremature laborUromodulinGlycosylation

Outcome Measures

Primary Outcomes (1)

  • Glycosylation changes in glycoproteins in urine

    In participating women who deliver preterm, the collected urine specimens will be analyzed to evaluate glycosylation changes in glycoproteins, specifically uromodulin.

    After delivery of preterm infant, less than one year

Study Arms (3)

prior preterm delivery at 24-32 weeks

collect their first morning urine samples before each of their remaining prenatal care appointments for our studies

Other: Urine samples

prior preterm delivery at 32-34 weeks

collect their first morning urine samples before each of their remaining prenatal care appointments for our studies

Other: Urine samples

prior preterm delivery at 34-36 weeks

collect their first morning urine samples before each of their remaining prenatal care appointments for our studies

Other: Urine samples

Interventions

Urine samplesOTHER

collect their first morning urine samples before each of their remaining prenatal care appointments for our studies

prior preterm delivery at 24-32 weeksprior preterm delivery at 32-34 weeksprior preterm delivery at 34-36 weeks

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women with a history of preterm delivery who are currently pregnant and receiving care at affiliates of the University of Missouri, including Missouri Ob/Gyn Associates, University of Missouri Women's and Children's Hospital, and University of Missouri Center for Maternal-Fetal-Medicine and Ultrasound Clinic.

You may qualify if:

  • Pregnant women with a history of preterm delivery

You may not qualify if:

  • Individuals that abuse alcohol or drugs
  • Individuals under the age of 18
  • Individuals that do not speak fluent English
  • Individuals with multifetal gestation
  • Individuals with known fetal anomaly
  • Individuals receiving heparin treatment during current pregnancy
  • Individuals with current or planned cervical cerclage
  • Individuals with hypertension requiring medication
  • Individuals with a seizure disorder
  • Individuals who plan to deliver at some location other than the University of Missouri affiliated hospitals
  • Individuals with a known abnormal fetal karyotype

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri Hospitals and Clinics

Columbia, Missouri, 65202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Michael W McCullough, MD

    University of Missouri Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

May 3, 2011

First Posted

May 5, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)