Protein and Ultrasound Indicators of Preterm Birth

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Colorado, Boulder
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01412931
First received: August 8, 2011
Last updated: December 6, 2013
Last verified: December 2013
  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

Further study details as provided by University of Colorado, Denver:

Biospecimen Retention:   Samples With DNA

Cervicovaginal fluid and placental membranes will be retained for study.


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412931

Locations
United States, Colorado
University of Colorado Hospital
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
University of Colorado, Boulder
Investigators
Principal Investigator: Virginia Ferguson, PhD University of Colorado, Boulder
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01412931     History of Changes
Other Study ID Numbers: 11-0570
Study First Received: August 8, 2011
Last Updated: December 6, 2013
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 July 26, 2014