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Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery

University of Missouri (MU) logo

University of Missouri (MU)

Status

Withdrawn

Conditions

Preterm Birth

Treatments

Other: Urine samples

Study type

Observational

Funder types

Other

Identifiers

NCT01348230
1179277

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

prior preterm delivery at 24-32 weeks
Description:
collect their first morning urine samples before each of their remaining prenatal care appointments for our studies
Treatment:
Other: Urine samples
prior preterm delivery at 32-34 weeks
Description:
collect their first morning urine samples before each of their remaining prenatal care appointments for our studies
Treatment:
Other: Urine samples
prior preterm delivery at 34-36 weeks
Description:
collect their first morning urine samples before each of their remaining prenatal care appointments for our studies
Treatment:
Other: Urine samples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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