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Protein and Ultrasound Indicators of Preterm Birth

22 april 2016 bijgewerkt door: University of Colorado, Denver

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Vroeggeboorte

Studietype

Observationeel

Inschrijving (Werkelijk)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Colorado
  - Denver, Colorado, Verenigde Staten, 80045
    - University of Colorado Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

14 jaar tot 45 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
1) Pregnant women with a single intrauterine pregnancy 50 women with uncomplicated pregnancies and no history of preterm birth.
2) Pregnant women with a single intrauterine pregnancy 50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM).
3) Pregnant women with a single intrauterine pregnancy 20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Changes in Serial Elastography Measurements Tijdsspanne: 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.	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).

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Changes in Biomechanical and biochemical analyses of the chorioamnion Tijdsspanne: 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.	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) Tijdsspanne: 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.	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 . Tijdsspanne: 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.	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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Colorado, Denver

Medewerkers

University of Colorado, Boulder

Onderzoekers

Hoofdonderzoeker: Virginia Ferguson, PhD, University of Colorado, Boulder

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2011

Primaire voltooiing (Werkelijk)

1 december 2013

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

8 augustus 2011

Eerst ingediend dat voldeed aan de QC-criteria