Clinical Trials Logo

Clinical Trial Summary

Birth exposes the newborn to oxidative stress, as due to the switch from a protected, relatively hypoxic intrauterine milieu into an environment with a high oxygen pressure. The full-term newborn is well prepared to this massive redox challenge at the time of birth due to his well-integrated antioxidant defenses. On the contrary, numerous bibliographical data and our own work demonstrate the fragility of preterm newborns in this context of oxidative stress, linked to the immaturity of his antioxidant defenses. Premature birth abruptly propels the fetus from the protected, relatively hypoxic intrauterine milieu to an environment at risk of free radical injury caused by mechanical ventilation strategies, including the use of high inspired oxygen fractions or inhaled nitric oxide, generating excessive reactive oxidative species (ROS). Several studies highlight the key role of ROS in adverse outcomes of preterm infant suffering from low birth weight, bronchopulmonary dysplasia, necrotizing enterocolitis or retinopathy. This project aims to evaluate a therapeutic anti-oxidative strategy in order to correct the oxidative status of preterm infants. The investigators propose an early intervention that consists in an antenatal maternal supplementation with N-acetylcysteine (NAC), the acetylated precursor of both cysteine and glutathione, a key physiological antioxidant. This strategy could be promising for the development of simplified and personalized care of preterm infants. GSH MAP is a randomized, single-blind, placebo-controlled study that aims to determine if NAC supplementation in women admitted to hospital care due to preterm labor (prior to 34 weeks of gestational age) may correct glutathione deficiency in neonatal cord blood.


Clinical Trial Description

GSH MAP is a randomized single-blind, placebo-controlled study. The design will include the recruitment of 120 pregnant women admitted to hospital care due to preterm labor (above 18 yrs of age, gestational age between 24 and 34 weeks). According to the risk of preterm delivery, women will be treated following two different schedules : - High risk of prematurity: NAC supplementation -9 g intravenously-6g/day per os until day 7-1,8g/day per os until 37 weeks of gestational age. - Moderate risk of prematurity: NAC supplementation -6g/day per os until day 7-1,8g/day per os until 37 weeks of gestational age. Biological samples collected: maternal blood at inclusion, maternal/cord blood and placenta at delivery, breast milk samples during the first week of lactation in case of exclusive breastfeeding. Levels of glutathione and related metabolites will be measured in plasma, red blood cells, placenta and breast milk. In ancillary studies, metabolome and lipidome profilings will be performed on maternal and cord blood and on breast milk samples. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03596125
Study type Interventional
Source Nantes University Hospital
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date November 5, 2018
Completion date November 11, 2021

See also
  Status Clinical Trial Phase
Completed NCT03304782 - Fitbit Activity Tracker to Predict Risk of Preterm Birth
Recruiting NCT02420743 - Serum Ferritin Concentration and Fetal MCA Doppler as Predictors for Preterm Delivery
Completed NCT01665378 - Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes N/A
Completed NCT01119963 - Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) Phase 2/Phase 3
Completed NCT00141908 - Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate Phase 2
Recruiting NCT05278130 - Serial Screening and Treatment of Bacterial Vaginosis Trial N/A
Recruiting NCT03123926 - Spontaneous Preterm Birth Marker Test N/A
Completed NCT00201643 - A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome Phase 4
Completed NCT01353807 - Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health N/A
Terminated NCT02545127 - Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely Phase 2
Completed NCT02371356 - Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health
Active, not recruiting NCT01009723 - Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers N/A
Completed NCT00883324 - Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum N/A
Completed NCT00615550 - PREGNANT Short Cervix Trial Phase 3
Completed NCT02694679 - Randomized Controlled Trial of Social Network Targeting in Honduras N/A
Completed NCT01031017 - Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies Phase 4
Completed NCT00329914 - Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies? Phase 2
Completed NCT00331695 - Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery Phase 4
Completed NCT01818518 - Neonatal Outcome by Reason for Delivery
Completed NCT04637880 - 25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders