Protein and Ultrasound Indicators of Preterm Birth

Study 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.

Official Title
-----------------
Protein and Ultrasound Indicators of Preterm Birth

Conditions
-----------------
Preterm Birth

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1) Pregnant women with a single intrauterine pregnancy<br>50 women with uncomplicated pregnancies and no history of preterm birth. | |
| 2) Pregnant women with a single intrauterine pregnancy<br>50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM). | |
| 3) Pregnant women with a single intrauterine pregnancy<br>20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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). | 
| 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). |