Preterm BirthNCT01348230
Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery
An observational study of Preterm Birth, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Urine samples
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Pregnant women with a history of preterm delivery
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Hospitals and Clinics
Columbia, Missouri, 65202
About this study
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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Urine samples
- Keywords
- Premature prolonged rupture of membranes, Premature labor, Uromodulin, Glycosylation
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine samplesOther
collect their first morning urine samples before each of their remaining prenatal care appointments for our studies
| Study group | Role | What they receive |
|---|---|---|
| prior preterm delivery at 24-32 weeks | collect their first morning urine samples before each of their remaining prenatal care appointments for our studies Receives: Other: Urine samples | |
| prior preterm delivery at 32-34 weeks | collect their first morning urine samples before each of their remaining prenatal care appointments for our studies Receives: Other: Urine samples | |
| prior preterm delivery at 34-36 weeks | collect their first morning urine samples before each of their remaining prenatal care appointments for our studies Receives: Other: Urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After delivery of preterm infant, less than one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael W McCullough, MD, Principal investigator, University of Missouri Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348230
- Sponsor's protocol ID
- 1179277
- Status last verified
- Apr 2017
- First submitted
- 3 May 2011
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycoproteomic Analysis of Urine in Women Undergoing Spontaneous Preterm Delivery
- ClinicalTrials.gov ID
- NCT01348230
- Acronym / sponsor ID
- 1179277
- Conditions
- Preterm Birth
- Keywords
- Premature prolonged rupture of membranes, Premature labor, Uromodulin, Glycosylation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prior preterm delivery at 24-32 weeks | – | Other: Urine samplescollect their first morning urine samples before each of their remaining prenatal care appointments for our studies |
| prior preterm delivery at 32-34 weeks | – | Other: Urine samplescollect their first morning urine samples before each of their remaining prenatal care appointments for our studies |
| prior preterm delivery at 34-36 weeks | – | Other: Urine samplescollect their first morning urine samples before each of their remaining prenatal care appointments for our studies |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Pregnant women with a history of preterm delivery
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine samplescollect their first morning urine samples before each of their remaining prenatal care appointments for our studies | Other | prior preterm delivery at 24-32 weeks, prior preterm delivery at 32-34 weeks, prior preterm delivery at 34-36 weeks |
Primary outcome
Glycosylation changes in glycoproteins in urine
Time frame: After delivery of preterm infant, less than one year
In participating women who deliver preterm, the collected urine specimens will be analyzed to evaluate glycosylation changes in glycoproteins, specifically uromodulin.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W McCullough, MD principal investigator
University of Missouri Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylation changes in glycoproteins in urine (time frame: After delivery of preterm infant, less than one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.