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Magnesium Effect on Embryonal PR Interval

Primary Purpose

Preterm Labor

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trans abdominal sonography
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preterm Labor

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women at risk for preterm labor before 32 week of gestation

Exclusion Criteria:

  • Fetal malformations
  • Maternal Lupus
  • Fetal conduction abnormalities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Women in risk for preterm labor

    Arm Description

    Women in risk for preterm labor treated with magnesium.

    Outcomes

    Primary Outcome Measures

    Prolonged PR interval
    PR will be measured by Mitral-aorta doppler

    Secondary Outcome Measures

    Full Information

    First Posted
    February 6, 2017
    Last Updated
    February 13, 2017
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03047304
    Brief Title
    Magnesium Effect on Embryonal PR Interval
    Official Title
    Magnesium Effect on Embryonal PR Interval
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 14, 2017 (Anticipated)
    Primary Completion Date
    February 10, 2018 (Anticipated)
    Study Completion Date
    March 10, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Magnesium is a known treatment for neuroprotection in preterm labor before 32 week of gestation. High concentration of Magnesium in the blood stream known as cause of conduction abnormalities and ECG changes such us prolonged QT, QRS and PR in about. The goal of our work is to evaluate the PR intervals in embryos after maternal treatment with magnesium during preterm labor.
    Detailed Description
    We will recruit 25 woman with threaten preterm labor, magnesium blood level and PR interval will be evaluated before magnesium loading dose (4gr) and 20 minutes after the loading dose. PR interval will be evaluated by Mitral-Aorta Doppler.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Labor

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Women in risk for preterm labor
    Arm Type
    Other
    Arm Description
    Women in risk for preterm labor treated with magnesium.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Trans abdominal sonography
    Intervention Description
    Trans abdominal sonography in order to measure fetal PR interval.
    Primary Outcome Measure Information:
    Title
    Prolonged PR interval
    Description
    PR will be measured by Mitral-aorta doppler
    Time Frame
    20 min after magnesium treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women at risk for preterm labor before 32 week of gestation Exclusion Criteria: Fetal malformations Maternal Lupus Fetal conduction abnormalities
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ola Gutzeit, MD
    Phone
    972543088220
    Email
    ola.gutzeit@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ola Gutzeit, MD
    Organizational Affiliation
    Principal Investigator
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    3552543
    Citation
    Gums JG. Clinical significance of magnesium: a review. Drug Intell Clin Pharm. 1987 Mar;21(3):240-6. doi: 10.1177/106002808702100301.
    Results Reference
    background
    PubMed Identifier
    1710436
    Citation
    Agus ZS, Morad M. Modulation of cardiac ion channels by magnesium. Annu Rev Physiol. 1991;53:299-307. doi: 10.1146/annurev.ph.53.030191.001503. No abstract available.
    Results Reference
    background
    PubMed Identifier
    10994748
    Citation
    Laurant P, Touyz RM. Physiological and pathophysiological role of magnesium in the cardiovascular system: implications in hypertension. J Hypertens. 2000 Sep;18(9):1177-91. doi: 10.1097/00004872-200018090-00003.
    Results Reference
    background
    PubMed Identifier
    10913494
    Citation
    Glickstein JS, Buyon J, Friedman D. Pulsed Doppler echocardiographic assessment of the fetal PR interval. Am J Cardiol. 2000 Jul 15;86(2):236-9. doi: 10.1016/s0002-9149(00)00867-5. No abstract available.
    Results Reference
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    Magnesium Effect on Embryonal PR Interval

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