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NCT Number: NCT01412931

Protein and Ultrasound Indicators of Preterm Birth

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

14 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Hospital

Denver, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Changes in Biomechanical and biochemical analyses of the chorioamnion

    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).

    To quantify the strength and related mechanical properties, characterize the composition of the extracellular matrix, and characterize the secreted protein profile.

  2. Correlation of Protein and biochemical analysis of the cervicovaginal fluid (CVF)

    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).

    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.

  3. Stratification of Ultrasound parameters, chorioamnion biomechanical and biochemical properties, and CVF proteins .

    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).

    Identify specific values and biomarkers able to identify patients at risk of preterm labor and preterm birth.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • University of Colorado, Boulder

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2011
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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