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Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery

This study has been withdrawn prior to enrollment.
(Investigator left institution)
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01348230
First received: May 3, 2011
Last updated: September 29, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Preterm Birth
Other: Urine samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
Urine

Enrollment: 0
Study Start Date: May 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
collect their first morning urine samples before each of their remaining prenatal care appointments for our studies
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
collect their first morning urine samples before each of their remaining prenatal care appointments for our studies
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
collect their first morning urine samples before each of their remaining prenatal care appointments for our studies

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348230

Locations
United States, Missouri
University of Missouri Hospitals and Clinics
Columbia, Missouri, United States, 65202
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Michael W McCullough, MD University of Missouri Department of Obstetrics and Gynecology
  More Information

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01348230     History of Changes
Other Study ID Numbers: 1179277 
Study First Received: May 3, 2011
Last Updated: September 29, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:
Premature prolonged rupture of membranes
Premature labor
Uromodulin
Glycosylation

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

ClinicalTrials.gov processed this record on December 02, 2016