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

NCT03956121 | Completed

• 1 other identifier: PO18050
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Neuroprotection

Keywords

Prematurity; magnesium sulfate; fetal heart rate; short-term variability; fetal neuroprotection

Outcome Measures

Primary Outcomes (1)

• 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

  day 0

Secondary Outcomes (1)

• accelerations and decelerations of foetal rythm

  Day 0

Study Arms (2)

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

Control group

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

Interventions

injection of magnesium sulfate OTHER

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.

Exposed group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 20, 2019
• Study Start: May 4, 2018
• Primary Completion: September 2, 2018
• Study Completion: March 2, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-04

Locations

FR (1)