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Magnesium Sulfate (MgSO4) and Fetal Heart Rate (FHR) in Case of Prematurity

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ClinicalTrials.gov Identifier: NCT03956121
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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Brief Summary:

Type of study: prospective descriptive monocentric study

Population: 2 groups: -Exposed group: pregnant patient between 24AW+0day and 32AW+0day receiving magnesium sulfate for fetal neuroprotection in the doubt of premature delivery

  • Control group: pregnant patient between 32AW+1day and 35AW+0day in the same context not requiring magnesium sulfate due to their gestationnal age.

Criterion(s) of judgment: Appearance of a change in short-term variability after injection of magnesium sulfate in the exposed group compared to the control group.

Schedule: Inclusion from February 20 to August 31, 2018

Expected results and prospects:

The general impression during my semester at the Jeanne de Flandre maternity clinic in Lille was the variability improves after injection of the magnesium sulfate used in the premature infant as a neuroprotective. The investigators would like to proove that the use of magnesium sulfate as neuroprotective in premature fetuses would improve the fetal heart rate by increasing variability.

In the literature there are numerous publications on the effects of magnesium sulfate used as tocolytic (higher doses) in the threats of premature labour, generally showing a variability and number accelerations decreases without increase the number of decelerations. Is this effect is the same as the doses used for fetal neuroprotection?

Expected benefits of the research:

Magnesium sulfate used on premature infants for fetal neuroprotection has an impact on fetal heart rate, including variability and number of accelerations.


Condition or disease Intervention/treatment
Fetal Neuroprotection Other: injection of magnesium sulfate

Detailed Description:

Investigation plan:

Exposed group: fetuses aged 24 + 0AW to 32 + 0AW and benefiting from MgSO4 for neuroprotective purposes, with decision of extraction or spontaneous labour or induced labour:

1 FHR + STV before MgSO4 bolus

  1. FHR + STV 10 minutes after the start of the MgSO4 bolus

    Control group: fetuses aged 32 + 1SA to 35 + 0SA without MgSO4, with extraction decision or spontaneous labour or induced labour:

  2. FHR + STV at 10 minutes interval : 1 STV at the entrance if suspicion premature labour (in the delivery room) then another 10 minutes after; 2 STV at 10 minutes interval if extraction decision.

Statistical Analysis Plan:

Measurement of the STV value difference before / after MgSO4 in the exposed group and the STV value difference between the 2 measurements in the control group and comparison of these differences.

Study Design
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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Magnesium Sulfate for Fetal Neuroprotection on Fetal Heart Rate in Case of Prematurity
Actual Study Start Date : May 4, 2018
Actual Primary Completion Date : September 2, 2018
Actual Study Completion Date : March 2, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Exposed group
Exposed group( with magnesium sulfate): fetuses aged 24 + 0AW to 32 + 0AW and benefiting from MgSO4 for neuroprotective purposes, with decision of extraction or spontaneous or induced labour
 Other: injection of magnesium sulfate
The intervention consists to perform a study of the usual fetal heart rate with, in addition, comparison analysis of the short-term variability before and after injection of magnesium sulfate in the exposed group. Two successive short-term variability analyzes will be performed in fetuses of the control group.
Control group
Control group (without magnesium sulfate) : fetuses aged 32 + 1SA to 35 + 0SA without MgSO4, with extraction decision or spontaneous or induced labour


Outcome Measures
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Primary Outcome Measures :
  1. Short term Variability of foetal rythm [ Time Frame: day 0 ]
    the short-term variability measure corresponds to the beat-to-beat fluctuation, within periods of 3.75 seconds. it is measured using an Oxford type of monitoring thanks to an algorithm


Secondary Outcome Measures :
  1. accelerations and decelerations of foetal rythm [ Time Frame: Day 0 ]
    number of accelerations and number of deceleration, within periods of 3.75 seconds. it is measured using an Oxford type of monitoring thanks to an algorithm


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Exposed group( with magnesium sulfate): fetuses aged 24 + 0AW to 32 + 0AW and benefiting from MgSO4 for neuroprotective purposes, with decision of extraction or spontaneous or induced labour Control group (without magnesium sulfate) : fetuses aged 32 + 1SA to 35 + 0SA without MgSO4, with extraction decision or spontaneous or induced labour
Criteria

Inclusion Criteria:

Exposed group: fetuses aged 24 + 0AW to 32 + 0AW and benefiting from MgSO4 for neuroprotective purposes, with decision of extraction or spontaneous labour or induced labour:

1 FHR + STV before MgSO4 bolus

  1. FHR + STV 10 minutes after the start of the MgSO4 bolus

    Control group: fetuses aged 32 + 1SA to 35 + 0SA without MgSO4, with extraction decision or spontaneous labour or induced labour:

  2. FHR + STV at 10 minutes interval : 1 STV at the entrance if suspicion premature labour (in the delivery room) then another 10 minutes after; 2 STV at 10 minutes interval if extraction decision.

Choice of the time of realization of the STV = MgSO4 cross almost immediately the placental barrier after its administration.

Exclusion Criteria:

  • Term of labour placement or delivery <24AW or > 35AW1day
  • Absence of maternal consent
  • Absence of realization of magnesium sulfate in the exposed group by maternal contraindication (Heart failure, Maternal heart rhythm disorder, Digitalis treatment, Severe hydro-electrolytic disorders, Renal insufficiency known or oligoanuria, Myasthenia, Maternal or fetal distress requiring a emergency extraction (<30min delay))
  • Absence / impossibility of realization of the STV in the exposed or control group.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956121


Locations
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France
Damien JOLLY
Reims, France
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03956121    
Other Study ID Numbers: PO18050
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Prematurity
magnesium sulfate
fetal heart rate
short-term variability
fetal neuroprotection
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
 Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents