- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03956121
Magnesium Sulfate (MgSO4) and Fetal Heart Rate (FHR) in Case of Prematurity
Effect of Magnesium Sulfate for Fetal Neuroprotection on Fetal Heart Rate in Case of Prematurity
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
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:
- 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Reims, France
- Damien JOLLY
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Premature Birth
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- PO18050
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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