Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Protein and Ultrasound Indicators of Preterm Birth

This study has been completed.
Sponsor:
Collaborator:
University of Colorado, Boulder
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01412931
First received: August 8, 2011
Last updated: April 22, 2016
Last verified: April 2016
  Purpose
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.

Condition
Preterm Birth

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Protein and Ultrasound Indicators of Preterm Birth

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Changes in Serial Elastography Measurements [ Time Frame: Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day). ] [ Designated as safety issue: No ]
    Serial elastography measurements will enable us to quantify changes in tissue modulus and structure longitudinally through normal, term pregnancy.


Secondary Outcome Measures:
  • Changes in Biomechanical and biochemical analyses of the chorioamnion [ Time Frame: Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day). ] [ Designated as safety issue: No ]
    To quantify the strength and related mechanical properties, characterize the composition of the extracellular matrix, and characterize the secreted protein profile.

  • Correlation of Protein and biochemical analysis of the cervicovaginal fluid (CVF) [ Time Frame: Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day). ] [ Designated as safety issue: No ]
    Protein and biochemical analysis of the CVF, and correlation with cervical tissue stiffness and morphology, will enable detection of specific bio-markers that are present during normal and premature cervical ripening.

  • Stratification of Ultrasound parameters, chorioamnion biomechanical and biochemical properties, and CVF proteins . [ Time Frame: Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day). ] [ Designated as safety issue: No ]
    Identify specific values and biomarkers able to identify patients at risk of preterm labor and preterm birth.


Biospecimen Retention:   Samples With DNA
Cervicovaginal fluid and placental membranes will be retained for study.

Enrollment: 3
Study Start Date: September 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1) Pregnant women with a single intrauterine pregnancy
50 women with uncomplicated pregnancies and no history of preterm birth.
2) Pregnant women with a single intrauterine pregnancy
50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM).
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.

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with a single intrauterine pregnancy with good gestational age dating, and live fetus with no indications for preterm delivery will be enrolled. Three groups of subjects will be recruited: a) 50 women with uncomplicated pregnancies and no history of preterm birth, b) 50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM) c) 20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth. Pregnant women of all races and ethnicities will be recruited into the study.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412931

Locations
United States, Colorado
University of Colorado Hospital
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
University of Colorado, Boulder
Investigators
Principal Investigator: Virginia Ferguson, PhD University of Colorado, Boulder
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01412931     History of Changes
Other Study ID Numbers: 11-0570 
Study First Received: August 8, 2011
Last Updated: April 22, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 23, 2016