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.

Study Overview

• Status: Withdrawn
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Urine samples

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65202
      • University of Missouri Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycosylation changes in glycoproteins in urine	In participating women who deliver preterm, the collected urine specimens will be analyzed to evaluate glycosylation changes in glycoproteins, specifically uromodulin.	After delivery of preterm infant, less than one year

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Michael W McCullough, MD, University of Missouri Department of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: May 4, 2011
• First Posted (Estimate): May 5, 2011

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Uromodulin; Glycosylation; Premature prolonged rupture of membranes; Premature labor
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 1179277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO