Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery
Recruitment status was Not yet recruiting
|First Received Date ICMJE||May 3, 2011|
|Last Updated Date||May 4, 2011|
|Start Date ICMJE||May 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01348230 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery|
|Official Title ICMJE||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.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples Without DNA
|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.
|Intervention ICMJE||Other: No interventions.
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||30|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 50 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01348230|
|Other Study ID Numbers ICMJE||1179277|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Michael Wayne McCullough, MD, University of Missouri Department of Obstetrics and Gynecology|
|Study Sponsor ICMJE||University of Missouri-Columbia|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Missouri-Columbia|
|Verification Date||May 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP