Protein and Ultrasound Indicators of Preterm Birth
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Purpose
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.
| Condition |
|---|
|
Preterm Birth |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Protein and Ultrasound Indicators of Preterm Birth |
Cervicovaginal fluid and placental membranes will be retained for study.
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 14 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Contact: Meghan A Donnelly, MD | 3037242032 | meghan.donnelly@ucdenver.edu |
| United States, Colorado | |
| University of Colorado Hospital | Not yet recruiting |
| Denver, Colorado, United States, 80045 | |
| Contact: Meghan A Donnelly, MD 303-724-2032 meghan.donnelly@ucdenver.edu | |
| Principal Investigator: | Virginia Ferguson, PhD | University of Colorado, Boulder |
More Information
No publications provided
| Responsible Party: | Virginia Ferguson, PhD, University of Colorado, Boulder |
| ClinicalTrials.gov Identifier: | NCT01412931 History of Changes |
| Other Study ID Numbers: | UCH 11-0570 |
| Study First Received: | August 8, 2011 |
| Last Updated: | August 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on June 13, 2013