Protein and Ultrasound Indicators of Preterm Birth
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- University of Colorado, Denver
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Changes in Serial Elastography Measurements
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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).
Serial elastography measurements will enable us to quantify changes in tissue modulus and structure longitudinally through normal, term pregnancy.
Secondary Outcomes
- 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).)
- 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).)
- 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).)