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Trial record 9 of 29 for:    GUSB

The Expression Heparanase in Term and Preterm Placentas

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ClinicalTrials.gov Identifier: NCT03798964
Recruitment Status : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:

Heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM).

This study aims to investigate the association between heparanase expression in the human placenta and preterm birth (PTB) .

The investigators hypothesize that an abnormal placentation causes relative placental ischemia that induces higher rates of heparanase expression.


Condition or disease Intervention/treatment
Preterm Birth Other: Placental analysis

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Expression Heparanase in Term and Preterm Placentas
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Group/Cohort Intervention/treatment
Elective term cesarean
Low-risk women undergoing elective term cesarean section
Other: Placental analysis
Analysis of placenta to determine expression of heparanase

Term vaginal delivery
Low-risk women undergoing term vaginal delivery
Other: Placental analysis
Analysis of placenta to determine expression of heparanase

Preterm vaginal delivery
Women undergoing preterm vaginal delivery
Other: Placental analysis
Analysis of placenta to determine expression of heparanase




Primary Outcome Measures :
  1. Heparanase expression [ Time Frame: Six months ]
    Heparanase expression in the human placenta following delivery will be evaluated by western blot analysis in the three groups and will be compared to determine differences in the levels.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women attending our obstetrical unit
Criteria

Inclusion Criteria:

  • Singleton pregnancy

Exclusion Criteria:

  • High-risk patients
  • Multiple pregnancy
  • Significant maternal illness
  • Significant fetal anomaly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798964


Contacts
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Contact: Amir Naeh, MD 972-52-8656506 amir_naeh@hotmail.com

Locations
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Israel
Hille Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Amir Naeh, MD       amir_naeh@hotmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Rinat Gabbay-Benziv, MD Hillel Yaffe Medical Center

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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03798964     History of Changes
Other Study ID Numbers: HYMC-0119-18
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications