Fetal NeuroprotectionNCT03956121
Magnesium Sulfate (MgSO4) and Fetal Heart Rate (FHR) in Case of Prematurity
An observational study of Fetal Neuroprotection, run by CHU de Reims at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Neuroprotection
- What is being tested?
- injection of magnesium sulfate
- Type of treatment
- Injection or infusion
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2018to 2 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
- 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.
Read the 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.
- Conditions
- Fetal Neuroprotection
- Being tested
- injection of magnesium sulfate
- Keywords
- Prematurity, magnesium sulfate, fetal heart rate, short-term variability, fetal neuroprotection
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of magnesium sulfateOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: injection of magnesium sulfate | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Short term Variability of foetal rythm
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
Measured: day 0
Secondary outcomes (1)
accelerations and decelerations of foetal rythm
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start4 May 2018
- Primary completion2 Sep 2018
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal NeuroprotectionStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956121
- Sponsor's protocol ID
- PO18050
- Status last verified
- Apr 2019
- First submitted
- 9 Apr 2018
- Last updated
- 20 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulfate for Fetal Neuroprotection on Fetal Heart Rate in Case of Prematurity
- ClinicalTrials.gov ID
- NCT03956121
- Acronym / sponsor ID
- PO18050
- Conditions
- Fetal Neuroprotection
- Keywords
- Prematurity, magnesium sulfate, fetal heart rate, short-term variability, fetal neuroprotection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Other: injection of magnesium sulfateExposed 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 | – | –Control group (without magnesium sulfate) : fetuses aged 32 + 1SA to 35 + 0SA without MgSO4, with extraction decision or spontaneous or induced labour |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of magnesium sulfateThe 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. | Other | Exposed group |
Primary outcome
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
1 secondary outcome
accelerations and decelerations of foetal rythm
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
Related trials for Fetal Neuroprotection
RecruitingPhase 1
Neonatal White Matter Injury Trial (WRAP)
White Matter Injury, Brain Injury, Fetus and Neonate
RecruitingPhase 3
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
Fetal Growth Retardation, Stillbirth and Fetal Death
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Neuroprotection, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term Variability of foetal rythm (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.