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Protein and Ultrasound Indicators of Preterm Birth

NCT ID: NCT01412931

Last Updated: 2016-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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Women are being asked to participate in a research study that is looking for new methods to understand and predict premature birth (birth before 37 weeks of pregnancy-full term pregnancy is 40 weeks). In this study the investigators will be looking at proteins in vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and stiffness, in order to try to know who will have a preterm birth and who will reach full term. The investigators will collect the vaginal fluid samples and perform ultrasounds both in the clinic throughout pregnancy in normal women, and from women admitted to the hospital because they are in early labor. The investigators will collect the placental tissue after the baby is born (this is normally discarded). This study will help us to understand the process of preterm birth and the investigators hope that this will eventually allow us to develop better methods to treat preterm labor and prevent the birth of premature babies.

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Detailed Description

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Conditions

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Preterm Birth

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1) Pregnant women with a single intrauterine pregnancy

50 women with uncomplicated pregnancies and no history of preterm birth.

No interventions assigned to this group

2) Pregnant women with a single intrauterine pregnancy

50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM).

No interventions assigned to this group

3) Pregnant women with a single intrauterine pregnancy

20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Single live intrauterine pregnancy
* Good gestational age dating

Exclusion Criteria

* History of prior cervical procedure such as LEEP, CKC, or cryotherapy
* Maternal or fetal indication for preterm delivery
* Cerclage in place
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Boulder

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginia Ferguson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Locations

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University of Colorado Hospital

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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11-0570

Identifier Type: -

Identifier Source: org_study_id

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