Evidence map›Paper›PMID 42177307›Full record

ArticlePediatric research2026

Antenatal N-acetylcysteine supplementation in pregnant women with impending preterm birth: a prospective randomized placebo-controlled trial.

Alice Küster, Arnaud Legrand, Marie-Anne Vibet, Phuong-Chi Nguyen, Norbert Winer, Margot Barribaud, Mathilde Gourdel, Marion Boivin, Morgane Vincke, Laurent Flet and 2 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Pediatric research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03596125 (Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03596125 phase2 / phase3terminatednot on this map

Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth

TypeinterventionalSponsorNantes University HospitalRan2018 to 2021Enrolled39ConditionsPreterm DeliveryArmsN-acetylcysteine, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Alice KüsterPediatric Intensive Care and Rare Inborn Errors of Metabolism, University Hospital of Nantes, Nantes, France. alice.kuster@chu-nantes.fr.
Arnaud LegrandInvestigation Department, Direction of Research and Innovation, Nantes Université, CHU Nantes, Nantes, France.
Marie-Anne VibetCHU Nantes, Direction of Research and Innovation, Methodology and Biostatistics Platform, Nantes Université, Nantes, France.
Phuong-Chi NguyenINRAE, UMR 1280, PhAN, CHU Nantes, Nantes Université, Nantes, France.
Norbert WinerINRAE, UMR 1280, PhAN, CHU Nantes, Nantes Université, Nantes, France.
Margot BarribaudCHU Nantes, Direction of Research and Innovation, Methodology and Biostatistics Platform, Nantes Université, Nantes, France.
Mathilde GourdelCHU Nantes, Inserm, CNRS, SFR Santé, Inserm UMS 016, Nantes Université, Nantes, France.
Marion BoivinCentre d'Investigation Clinique CIC 1413, INSERM, CHU de Nantes, Nantes, France.
Morgane VinckeCentre d'Investigation Clinique CIC 1413, INSERM, CHU de Nantes, Nantes, France.
Laurent FletCHU Nantes, Pharmacy, Nantes Université, Nantes, France.
Dominique DarmaunINRAE, UMR 1280, PhAN, CHU Nantes, Nantes Université, Nantes, France.
Marie-Cecile Alexandre-GouabauINRAE, UMR 1280, PhAN, CHU Nantes, Nantes Université, Nantes, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDepletion of glutathione (GSH) stores is associated with preterm birth and is not corrected by neonatal supplementation with N-acetylcysteine (NAC), a GSH precursor. Whether antenatal NAC would do so, remains unknown.

methodsIn a pilot, randomized, single-blinded trial (NCT03596125), women pregnant with singletons at-either severe or moderate-risk for impending preterm birth, received either N-acetylcysteine (n = 20) or placebo (n = 19). The moderate-risk group received oral NAC (80 mg/kg/day, days 0-7, then 40 mg/kg/day until 37 weeks or delivery). The severe-risk group, received an intravenous bolus (20 mg/kg over 1 h) and infusion (105 mg/kg over 4 h) doses prior to oral NAC. Primary outcome was umbilical venous cord erythrocyte GSH; secondary included pregnancy-duration, infant outcomes, and exploratory investigation of sulfur metabolites.

resultsNAC supplementation failed to impact median GSH (full analysis set/per protocol: 402/465 vs. 459/398 µmol/L, P 0.38/1.0). However, NAC was associated with prolonged pregnancy duration (44.5 vs. 36 days), a larger number of infants free of neonatal complications (17 (85%) vs. 10 (52.6%)), and altered sulfur pathways.

conclusionsIn pregnancies at risk for preterm delivery, high-dose N-acetylcysteine failed to restore glutathione levels but was safe. The trend toward prolonged pregnancy and reduced neonatal morbidity would require confirmation in larger trials. IMPACT: High-dose NAC administration is safe in pregnancies at risk of preterm delivery. Antenatal NAC administration did not significantly alter neonatal glutathione concentrations. Antenatal NAC administration was associated with prolonged pregnancy and reduced neonatal morbidity in pregnancies at risk of preterm delivery. Antenatal NAC administration was associated with changes in maternal and neonatal blood metabolomic signatures related to sulfur and nitric-oxide pathways.

Identifiers

PMID42177307

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.