Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery
| Status: | Withdrawn |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2017 |
| Start Date: | May 2011 |
| End Date: | September 2013 |
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.
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.
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.
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
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