Magnesium Effect on Embryonal PR Interval

February 13, 2017 updated by: Ola Gutzeit MD, Rambam Health Care Campus
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Fetal malformations
  • Maternal Lupus
  • Fetal conduction abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Women in risk for preterm labor
Women in risk for preterm labor treated with magnesium.
Diagnostic test: Trans abdominal sonography
Trans abdominal sonography in order to measure fetal PR interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolonged PR interval
Time Frame: 20 min after magnesium treatment
PR will be measured by Mitral-aorta doppler
20 min after magnesium treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Ola Gutzeit, MD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 14, 2017

Primary Completion (Anticipated)

February 10, 2018

Study Completion (Anticipated)

March 10, 2018

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0531-15-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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