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PAR Family Polymorphisms and Placental Invasion Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00425867
First received: January 22, 2007
Last updated: January 25, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention
Miscarriage, Recurrent
Premature Labor
Behavioral: PAR1 polymoprhisms and placental invasion

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Estimated Enrollment: 100
Study Start Date: March 2007
Estimated Study Completion Date: November 2007
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women with reccurent abortions unexplained
  • Premature delicery

Exclusion Criteria:

  • Term pregnancies
  • Abortion that the cause is known
  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: NCT00425867

Contacts
Contact: Sorina Grisaru, MD 97226555111 granovsky@netvision.net.il

Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Sorina Grisaru, MD Shaare Zedek Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00425867     History of Changes
Other Study ID Numbers: PAR1 polymorphisms
Study First Received: January 22, 2007
Last Updated: January 25, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
PAR1 gene
polymorphisms
abortions
reccurent abortions
premature delivery

Additional relevant MeSH terms:
Abortion, Habitual
Obstetric Labor, Premature
Abortion, Spontaneous
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on November 20, 2014