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PAR Family Polymorphisms and Placental Invasion Disorders

25. januar 2007 opdateret af: Shaare Zedek Medical Center
The present study will be undertaken to establish whether genetic variations of PAR1 could be involved in the occurrence of any of the "placental syndromes" of preterm delivery, preeclampsia, and/or small for gestational age babies and recurrent pregnancy loss.

Studieoversigt

Detaljeret beskrivelse

Polymorphisms of Protease Activated Receptor 1 and adverse pregnancy outcomes Protease Activated Receptor 1 (PAR1), the main thrombin receptor on vascular cells (Coughlin,1999), plays a critical role in orchestrating human placentation based on temporally and spatially constrained PAR1 expression in the normal invasive trophoblasts (O'Brien et al, 2003) and its overexpression in pathological invasive trophoblast (Even-Ram et al, 2003).

Various proteases of the PAR family as well as matrix metalloproteinases have been implicated in ancillary regulation of cancer metastases and tumor-related angiogenesis. PAR1 in particular has been proposed to be involved in invasive processes of various cancers (Ruf & Mueller, 2006; Boire et al, 2005). Similarly, it might be surmised that remodeling of the placenta microenvironment as well as the requisites of trophoblast invasiveness may be PAR1 sensitive (Grisaru-Granovsky et al, 2005). Therefore, one might hypothesize that PAR1 gene variability may be involved in early placentation and that adverse pregnancy outcomes of the "placental syndromes" may have their origin in PAR1 dysregulation.

Study Design: This is a prospective case-control pilot study. Subject enrolment and data collection will be performed via the Admission Service of the Division for Maternal & Fetal Medicine in a large tertiary obstetrics department in Jerusalem, Israel. Demographic data including maternal characteristics, past reproductive history, and information about previous complications during pregnancy, delivery and the neonatal period will be culled. The blood samples will be collected at routine admission after obtaining informed consent by the physician on the floor.

Four groups are described: patients with spontaneous preterm delivery of a singleton before 35 weeks of gestation; patients with a singleton pregnancy complicated by preeclampsia diagnosed according the Working Group Criteria (2000); patients who deliver a small for gestational age (SGA) singleton defined as a birth weight below the 10th percentile for the gestational age according to the Israeli growth curves (Dollberg et al, 2005); and for comparison, patients who deliver a singleton at term with appropriate size for gestational age. Patients who suffer delivery with intrauterine fetal demise and/or neonates with malformations will be excluded.

Maternal and umbilical cord blood samples (in 0.11mol/l sodium tri citrate) will be paired. DNA will be prepared from white blood cells by standard techniques and subsequently stored at -4°C for batched analysis. The laboratory staff will be blinded as to the clinical status of the samples.

Polymorphism analysis will be performed for the following polymorphisms of the PAR1 gene: [-1426CT], [506 insertion of 13 bp],[IVS-14A/T]: as per standard PCR techniques using appropriate restriction endonucleases (Arnaud et l, 2000).

Undersøgelsestype

Observationel

Tilmelding

100

Kontakter og lokationer

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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

20 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women with reccurent abortions unexplained
  • Premature delicery

Exclusion Criteria:

  • Term pregnancies
  • Abortion that the cause is known

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Sorina Grisaru, MD, Shaare Zedek Medical Center

Publikationer og nyttige links

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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. marts 2007

Studieafslutning

1. november 2007

Datoer for studieregistrering

Først indsendt

22. januar 2007

Først indsendt, der opfyldte QC-kriterier

22. januar 2007

Først opslået (Skøn)

23. januar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. januar 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2007

Sidst verificeret

1. januar 2007

Mere information

Begreber relateret til denne undersøgelse

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 .

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