Protein and Ultrasound Indicators of Preterm Birth

Completed

• Conditions: Preterm Birth

• Registration Number: NCT01412931
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Study Start: 2011-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• Single live intrauterine pregnancy
• Good gestational age dating

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Serial Elastography Measurements	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).	Serial elastography measurements will enable us to quantify changes in tissue modulus and structure longitudinally through normal, term pregnancy.

Secondary Outcome Measures

Name	Time	Method
Changes in Biomechanical and biochemical analyses of the chorioamnion	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).	To quantify the strength and related mechanical properties, characterize the composition of the extracellular matrix, and characterize the secreted protein profile.
Stratification of Ultrasound parameters, chorioamnion biomechanical and biochemical properties, and CVF proteins .	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).	Identify specific values and biomarkers able to identify patients at risk of preterm labor and preterm birth.
Correlation of Protein and biochemical analysis of the cervicovaginal fluid (CVF)	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).	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.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Denver, Colorado, United States