Magnesium Effect on Embryonal PR Interval | NCT03047304

Studies
Magnesium Effect on Embryonal PR Interval

NCT03047304

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Feb 15, 2017Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Preterm Labor

Interventions

Trans abdominal sonography

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2017Estimated

Primary Completion Date

Feb 10, 2018Estimated

Completion Date

Mar 10, 2018Estimated

First Submitted Date

Feb 6, 2017

First Submission Date that Met QC Criteria

Feb 6, 2017

First Posted Date

Feb 8, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2017

Last Update Posted Date

Feb 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women in risk for preterm labor	Other	Women in risk for preterm labor treated with magnesium.	Diagnostic Test: Trans abdominal sonography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trans abdominal sonography	Diagnostic Test	Trans abdominal sonography in order to measure fetal PR interval.	Women in risk for preterm labor

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women at risk for preterm labor before 32 week of gestation

Exclusion Criteria:

Fetal malformations
Maternal Lupus
Fetal conduction abnormalities

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ola Gutzeit, MD	Contact	972543088220		ola.gutzeit@gmail.com

Overall Officials

Name	Affiliation	Role
Ola Gutzeit, MD	Principal Investigator	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3552543	Background	Gums JG. Clinical significance of magnesium: a review. Drug Intell Clin Pharm. 1987 Mar;21(3):240-6. doi: 10.1177/106002808702100301.
1710436	Background	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.

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases