Clinical trial NCT01412931: Protein and Ultrasound Indicators of Preterm Birth
Official title: Protein and Ultrasound Indicators of Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Colorado, Boulder
First posted: 2011-08-09
Enrollment: 3
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Changes in Serial Elastography Measurements
timeFrame: 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 outcomes:
measure: Changes in Biomechanical and biochemical analyses of the chorioamnion
timeFrame: 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).
measure: Correlation of Protein and biochemical analysis of the cervicovaginal fluid (CVF)
timeFrame: 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).
measure: Stratification of Ultrasound parameters, chorioamnion biomechanical and biochemical properties, and CVF proteins .
timeFrame: 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).
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Virginia Ferguson, PhD
role: PRINCIPAL_INVESTIGATOR
References: