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NCT03047304 Clinical Trial

Magnesium Effect on Embryonal PR Interval

Preterm Labor Clinical Trial

Official title:
Magnesium Effect on Embryonal PR Interval

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03047304
Other study ID # 0531-15-RMB
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 6, 2017
Last updated February 13, 2017
Start date February 14, 2017
Est. completion date March 10, 2018

Study information
Verified date February 2017
Source Rambam Health Care Campus
Contact Ola Gutzeit, MD
Phone 972543088220
Email ola.gutzeit@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date March 10, 2018
Est. primary completion date February 10, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Fetal malformations

- Maternal Lupus

- Fetal conduction abnormalities

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Trans abdominal sonography
Trans abdominal sonography in order to measure fetal PR interval.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

References & Publications (4)

Agus ZS, Morad M. Modulation of cardiac ion channels by magnesium. Annu Rev Physiol. 1991;53:299-307. Review. — View 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. — View Citation

Gums JG. Clinical significance of magnesium: a review. Drug Intell Clin Pharm. 1987 Mar;21(3):240-6. Review. — View 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Prolonged PR interval PR will be measured by Mitral-aorta doppler 20 min after magnesium treatment
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