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
About this trial
This is an interventional diagnostic trial for Preterm Labor
Eligibility Criteria
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
NCT ID
NCT03047304
First Posted
February 6, 2017
Last Updated
February 13, 2017
Sponsor
Rambam Health Care Campus
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
background
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Magnesium Effect on Embryonal PR Interval
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