NCT03596125

Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)

Terminated Phase 2, PHASE3 Last updated 19 December 2022

What this trial tests

Phase 2, PHASE3 trial testing N-acetylcysteine in Preterm Delivery in 39 participants. Terminated before completion.

Timeline

5 November 2018

Primary endpoint
11 November 2021

11 November 2021

Quick facts

Lead sponsor	Nantes University Hospital
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	39
Start date	5 November 2018
Primary completion	11 November 2021
Estimated completion	11 November 2021
Sites	1 location across France

Drugs / interventions tested

• N-acetylcysteine — full drug profile →
• Placebo

Conditions studied

• Preterm Delivery — all drugs for Preterm Delivery →

Sponsor

Nantes University Hospital

Who can join

18 and older, female only, with Preterm Delivery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Anti-oxidative stress treatment and current clinical trials.
   Zhang CY, Yang M. · · 2024 · cited 3× · PMID 38495278 · DOI 10.4254/wjh.v16.i2.294
2. Antenatal N-acetylcysteine supplementation in pregnant women with impending preterm birth: a prospective randomized placebo-controlled trial.
   Küster A, Legrand A, Vibet MA, Nguyen PC, et al · · 2026 · PMID 42177307 · DOI 10.1038/s41390-026-05083-4