NCT03047304

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

February 14, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2018

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

12 months

First QC Date

February 6, 2017

Last Update Submit

February 13, 2017

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

  • Prolonged PR interval

    PR will be measured by Mitral-aorta doppler

    20 min after magnesium treatment

Study Arms (1)

Women in risk for preterm labor

OTHER

Women in risk for preterm labor treated with magnesium.

Diagnostic Test: Trans abdominal sonography

Interventions

Trans abdominal sonographyDIAGNOSTIC_TEST

Trans abdominal sonography in order to measure fetal PR interval.

Women in risk for preterm labor

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Fetal malformations
  • Maternal Lupus
  • Fetal conduction abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Gums JG. Clinical significance of magnesium: a review. Drug Intell Clin Pharm. 1987 Mar;21(3):240-6. doi: 10.1177/106002808702100301.

    PMID: 3552543BACKGROUND

  • 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.

    PMID: 1710436BACKGROUND

  • 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.

    PMID: 10994748BACKGROUND

  • 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.

    PMID: 10913494BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ola Gutzeit, MD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ola Gutzeit, MD

CONTACT

972543088220ola.gutzeit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 8, 2017

Study Start

February 14, 2017

Primary Completion

February 10, 2018

Study Completion

March 10, 2018

Last Updated

February 15, 2017

Record last verified: 2017-02