Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Venous umbilical cord blood concentration of glutathione (micromoles/L) following antenatal NAC supplementation. |
The venous umbilical cord blood concentration of glutathione will be measured in red blood cell lysates on C18-reverse phase column using liquid-chromatography combined to mass spectrometry. Homocysteine, cysteine, reduced (GSH) and oxidized (GSSG) glutathione levels will be measured in erythrocytes by comparing an experimental arm versus a placebo arm |
13 weeks |
|
Secondary |
Number of days between the NAC-therapeutic initialization and childbirth. |
The delay time (days) between delivery and inclusion of pregnant women admitted to hospital care due to preterm labor will be compared in an experimental arm versus a placebo arm. |
until childbirth |
|
Secondary |
Glutathione concentration in arterial blood at birth |
The arterial umbilical cord blood concentration of glutathione will be measured in red blood cell lysates on C18-reverse phase column using liquid-chromatography combined to mass spectrometry. Homocysteine, cysteine, reduced (GSH) and oxidized (GSSG) glutathione levels will be measured in erythrocytes by comparing an experimental arm versus a placebo arm |
13 weeks |
|
Secondary |
Maternal blood concentrations of glutathione (micromoles/L) and their total antioxidant capacity at inclusion. |
Changes in glutathione concentration (micromoles/L) in maternal red blood cells will be measured at inclusion and compared in an experimental arm versus a placebo arm. The maternal blood concentration of glutathione will be assessed as in the primary outcome measurement description. Total antioxidant capacity of maternal blood will be measured in plasma using kits such as Trolox Equivalent Antioxidant Capacity (TEAC) assay or lipid-peroxide secretion, measured by TBARS levels, combined to the measurement of levels of oxidized (carbonylated) proteins by mass spectrometry. |
18 weeks |
|
Secondary |
Maternal blood concentrations of glutathione (micromoles/L) and their total antioxidant capacity at delivery, following antenatal NAC supplementation. |
Changes in glutathione concentration (micromoles/L) in maternal red blood cells will be measured at delivery and compared in an experimental arm versus a placebo arm. The maternal blood concentration of glutathione will be assessed as in the primary outcome measurement description. Total antioxidant capacity of maternal blood will be measured in plasma using kits such as Trolox Equivalent Antioxidant Capacity (TEAC) assay or lipid-peroxide secretion, measured by TBARS levels, combined to the measurement of levels of oxidized (carbonylated) proteins by mass spectrometry. |
18 weeks |
|
Secondary |
Placental total antioxidant capacity at delivery |
Placental gene expression patterns of various enzymes involved in oxidative status such as superoxide dismutase, catalase and glutathione peroxidase and reductase will be measured in an experimental arm versus a placebo arm. Levels of free radical scavengers such as glutathione will be measured using liquid-chromatography combined to mass spectrometry. Placental total antioxidant capacity will be measured using TEAC or TBARS assays, combined to the measurement of levels of oxidized (carbonylated) proteins. |
at delivery |
|
Secondary |
Breast milk sulphur amino acid pattern on day 7 of the postpartum period following NAC supplementation. |
Colostrum or native breastmilk collected at day 7 will serve for determination of glutathione levels and other sulphur amino acids measured using liquid-chromatography combined to mass spectrometry. |
19 weeks |
|
Secondary |
Total antioxidant capacity on day 7 of the postpartum period following NAC supplementation. |
Total antioxidant capacity will be measured using TEAC or TBARS assays in combination with mass spectrometry assessment of oxidized (carbonylated) proteins. |
19 weeks |
|
Secondary |
Maternal metabolome and lipidome at delivery following the antenatal NAC supplementation. |
Metabolomic, lipidomic and amino acid patterns will be measured in maternal blood at GSH MAP-inclusion and at delivery using liquid-chromatography combined to mass spectrometry. The significance of the impact of NAC supplementation on these patterns will be assessed in link with maternal clinical data. |
18 weeks |
|
Secondary |
Weight variations |
Weight will be evaluated in the fetus by maternal ultra-sound scans and measured on the newborn at birth and during his hospital stay. The significance of the impact of antenatal NAC supplementation on the anthropometric fetal and newborn data will be assessed taking into account clinical data. |
Hospital discharge (4 months) |
|
Secondary |
Lenght variations |
Length will be evaluated in the fetus by maternal ultra-sound scans and measured on the newborn at birth and during his hospital stay. The significance of the impact of antenatal NAC supplementation on the anthropometric fetal and newborn data will be assessed taking into account clinical data. |
Hospital discharge (4 months) |
|
Secondary |
Head circumference variations |
Head circumference will be evaluated in the fetus by maternal ultra-sound scans and measured on the newborn at birth and during his hospital stay. The significance of the impact of antenatal NAC supplementation on the anthropometric fetal and newborn data will be assessed taking into account clinical data. |
Hospital discharge (4 months) |
|
Secondary |
Postnatal follow up of newborn blood concentration of glutathione during his first days of life. |
Newborn blood currently collected for clinical assessment during hospitalization will be analyzed in order to determine glutathione using liquid-chromatography combined to mass spectrometry. . |
from birth until hospital discharge (4 months) |
|
Secondary |
Postnatal follow up of newborn blood concentration of total antioxidant capacity during his first days of life. |
Newborn blood total antioxidant capacity will be measured using TEAC or TBARS assays. |
from birth until hospital discharge (4 months) |
|
Secondary |
Postnatal follow up of newborn blood concentration of and metabolome/lipidome during his first days of life. |
Newborn blood currently collected for clinical assessment during hospitalization will be analyzed in order to determine metabolome/lipidome using liquid-chromatography combined to mass spectrometry. |
from birth until hospital discharge (4 months) |
|
Secondary |
Improvement of the clinical outcome of the newborn until discharge from hospital. |
Clinical data in newborn until his discharge and frequency of postnatal pathologies associated with prematurity. |
4 months |
|