Protein and Ultrasound Indicators of Preterm Birth
22. april 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Colorado
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Denver, Colorado, Forenede Stater, 80045
- University of Colorado Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 45 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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1) Pregnant women with a single intrauterine pregnancy
50 women with uncomplicated pregnancies and no history of preterm birth.
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2) Pregnant women with a single intrauterine pregnancy
50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM).
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in Serial Elastography Measurements
Tidsramme: 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).
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Serial elastography measurements will enable us to quantify changes in tissue modulus and structure longitudinally through normal, term pregnancy.
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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).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in Biomechanical and biochemical analyses of the chorioamnion
Tidsramme: 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).
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To quantify the strength and related mechanical properties, characterize the composition of the extracellular matrix, and characterize the secreted protein profile.
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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).
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Correlation of Protein and biochemical analysis of the cervicovaginal fluid (CVF)
Tidsramme: 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).
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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.
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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).
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Stratification of Ultrasound parameters, chorioamnion biomechanical and biochemical properties, and CVF proteins .
Tidsramme: 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).
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Identify specific values and biomarkers able to identify patients at risk of preterm labor and preterm birth.
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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).
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Virginia Ferguson, PhD, University of Colorado, Boulder
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2011
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
8. august 2011
Først indsendt, der opfyldte QC-kriterier
8. august 2011
Først opslået (Skøn)
9. august 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11-0570
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med For tidlig fødsel
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University Hospitals Cleveland Medical CenterThe Cleveland Clinic; MetroHealth Medical CenterRekrutteringFor tidlig fødsel | Graviditet for tidligt | PROM (graviditet) | Graviditetsprom | PROM, for tidligt (graviditet) | Premat rupturmembraner Preterm Uspecificeret til længden af tid mellem ruptur/fødselForenede Stater
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Woman'sRekrutteringFor tidlig fødsel | For tidligt arbejde | Brud på membraner; For tidlig | Brud på membraner; Forsinket levering (efter spontan brud) | Brud på membraner; For tidligt, påvirker fosteret | Preterm PROM (graviditet)Forenede Stater