Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01348230
First received: May 3, 2011
Last updated: May 13, 2016
Last verified: May 2016

May 3, 2011
May 13, 2016
May 2011
Not Provided
Glycosylation changes in glycoproteins in urine [ Time Frame: After delivery of preterm infant, less than one year ] [ Designated as safety issue: No ]
In participating women who deliver preterm, the collected urine specimens will be analyzed to evaluate glycosylation changes in glycoproteins, specifically uromodulin.
Same as current
Complete list of historical versions of study NCT01348230 on ClinicalTrials.gov Archive Site
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Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery
Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery

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.

In this study, the investigators will identify women with a history of preterm delivery between 24-32 weeks, 32-34, and 34-36 weeks gestation based on diagnosis codes in the medical record who are currently pregnant. The investigators will ask these women when they are in the 16-20 week into their pregnancy to fill out a questionaire to determine study eligibility. If chosen to participate, the investigators will ask them to collect their first morning urine samples before each of their remaining prenatal care appointments for our studies. The investigators will also ask them if the investigators can check their medical records to determine if they later had a premature baby. If these women in either group give birth prematurely, then the investigators will analyze the glycoproteins in their urine samples using known values from women who did not have a premature birth as controls. If the investigators can see any changes in glycosylation in the women who gave birth prematurely, then this information will be used to apply for a larger study that will determine if such changes apply to all women. If it can then be shown to apply to all women, then the investigators may use it to predict preterm delivery. This information would allow physicians to design treatments to help these women and their babies, and spare them these disabilities. Some women go into labor prematurely, well before they should give birth. Physicians can intervene in some cases to stop labor, and allow the fetus to develop further in the mother's womb. However, in more than half the cases the physician cannot stop this process, and the baby is born prematurely.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
Urine
Probability Sample
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.
  • Preterm Birth
  • Obstetric Labor, Premature
  • Preterm PROM
  • Uromodulin
  • Glycosylation
Other: No interventions.
No interventions.
  • Prior delivery at 24-32 weeks gestation
    Women with a prior preterm delivery at 24-32 weeks gestation, not related to multiple gestation pregnancy.
    Intervention: Other: No interventions.
  • Prior preterm deliver at 32-34 weeks gestation
    Women with a prior preterm delivery at 32-34 weeks gestation, not related to multiple gestation pregnancy.
    Intervention: Other: No interventions.
  • Prior preterm delivery at 34-36 weeks gestation
    Women with a prior preterm delivery at 34-36 weeks gestation, not related to multiple gestation pregnancy.
    Intervention: Other: No interventions.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2013
Not Provided

Inclusion Criteria:

  • Pregnant women with a history of preterm delivery

Exclusion Criteria:

  • 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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01348230
1179277
Yes
Not Provided
Not Provided
University of Missouri-Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Michael W McCullough, MD University of Missouri Department of Obstetrics and Gynecology
University of Missouri-Columbia
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP