Protein and Ultrasound Indicators of Preterm Birth

Preterm Birth Clinical Trial

Official title:

Protein and Ultrasound Indicators of Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412931
• Other study ID #: 11-0570
• Status: Completed
• Phase: N/A
• First received: August 8, 2011
• Last updated: April 22, 2016
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Serial Elastography Measurements	Serial elastography measurements will enable us to quantify changes in tissue modulus and structure longitudinally through normal, term pregnancy.	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).	No
Secondary	Changes in Biomechanical and biochemical analyses of the chorioamnion	To quantify the strength and related mechanical properties, characterize the composition of the extracellular matrix, and characterize the secreted protein profile.	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).	No
Secondary	Correlation of Protein and biochemical analysis of the cervicovaginal fluid (CVF)	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.	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).	No
Secondary	Stratification of Ultrasound parameters, chorioamnion biomechanical and biochemical properties, and CVF proteins .	Identify specific values and biomarkers able to identify patients at risk of preterm labor and preterm birth.	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).	No