Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery
Recruitment status was Not yet recruiting
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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.
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.
| Condition | Intervention |
|---|---|
|
Preterm Birth Obstetric Labor, Premature Preterm PROM Uromodulin Glycosylation |
Other: No interventions. |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery |
- 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
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2011 |
| Groups/Cohorts | Assigned 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.
|
Other: No interventions.
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.
|
Other: No interventions.
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.
|
Other: No interventions.
No interventions.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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| Contact: Michael W McCullough, MD | (573) 817-3095 | mcculloughmw@health.missouri.edu |
| Contact: Amanda J Stephens, MD | (573) 499-6084 | stephensaj@health.missouri.edu |
| United States, Missouri | |
| University of Missouri Hospitals and Clinics | Not yet recruiting |
| Columbia, Missouri, United States, 65202 | |
| Contact: Michael W McCullough, MD 573-817-3095 mcculloughmw@health.missouri.edu | |
| Principal Investigator: Michael W McCullough, MD | |
| Sub-Investigator: Gary F Clark, PhD | |
| Sub-Investigator: Amanda J Stephens, MD | |
| Sub-Investigator: Mary L Smith, MD | |
| Principal Investigator: | Michael W McCullough, MD | University of Missouri Department of Obstetrics and Gynecology |
More Information
No publications provided
| Responsible Party: | Michael Wayne McCullough, MD, University of Missouri Department of Obstetrics and Gynecology |
| ClinicalTrials.gov Identifier: | NCT01348230 History of Changes |
| Other Study ID Numbers: | 1179277 |
| Study First Received: | May 3, 2011 |
| Last Updated: | May 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obstetric Labor, Premature Premature Birth Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on May 19, 2013