Effects of the Supplementation of N-acetylcysteine on Redox Imbalance, Cytokine Levels, and Perinatal Outcomes in Pregnant Women with Preeclampsia: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

Background/Objectives: This study aimed to evaluate the effects of oral administration of N-acetylcysteine (NAC) in pregnant women with preeclampsia (PE), using serum markers of redox imbalance and cytokine levels and perinatal outcomes. Methods: A double-blind, randomized, placebo-controlled pilot study was carried out from 2021 to 2023. The study was retrospectively registered with REBEC (Brazilian Clinical Trials Registry). After screening, women were randomized into 2 groups according to the type of supplementation: 600 mg of NAC (NAC group) or capsules containing 2% colloidal silicon dioxide and 98% microcrystalline cellulose (placebo group) until delivery. Blood samples were collected to quantify biomarkers of redox imbalance and cytokine levels. Questionnaires containing socioeconomic, clinical, obstetric, and anthropometric data were applied. Results: A total of 51 pregnant women with PE were included (26 in the placebo group and 25 in the NAC group). The use of NAC was associated with a higher gestational age at birth (GA) of the conceptus (placebo group: 37.39 weeks ± 1.96 SD vs. NAC group: 38.45 weeks ± 1.51 SD; p = 0.044). A moderate effect size was observed for this variable (Cohen’s d = 0.52). However, treatment allocation (NAC vs. control) was not independently associated with gestational age at birth after adjustment for covariates (F(1,28) = 0.144; p = 0.707; η2p = 0.005). The adjusted mean difference between groups was 0.92 weeks (95% CI: −0.16 to 2.00). No other significant effects on redox and inflammatory markers were identified using NAC. Conclusions: NAC supplementation did not impact the mode of delivery between the NAC and placebo groups. As a secondary exploratory finding, a possible trend toward prolonged gestational age was observed in the NAC group; however, this result should be interpreted with caution, given the exploratory nature of the analysis, the neutrality of the primary outcome, and the limited sample size.

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Journal
Pharmaceuticals
Published
2026-08-25
DOI
https://doi.org/10.3390/ph19091344
Primary Topic
Pregnancy and preeclampsia studies
Type
article
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article

Effects of the Supplementation of N-acetylcysteine on Redox Imbalance, Cytokine Levels, and Perinatal Outcomes in Pregnant Women with Preeclampsia: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

Alexandra Rodrigues Bezerra, Marília Oliveira Fonseca Goulart, Marilene Brandão Tenório Fragoso, Tauane Alves Dutra et al.
Pharmaceuticals
Pregnancy and preeclampsia studies
article

Effects of the Supplementation of N-acetylcysteine on Redox Imbalance, Cytokine Levels, and Perinatal Outcomes in Pregnant Women with Preeclampsia: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

Alexandra Rodrigues Bezerra, Marília Oliveira Fonseca Goulart, Marilene Brandão Tenório Fragoso, Tauane Alves Dutra, Fabiana Andréa Moura, Micaely Cristina dos Santos Tenório, Nassib Bezerra Bueno, Orlando Roberto Pimentel de Araújo, Nathálya da Silva Severino, Alane Cabral Menezes de Oliveira, Amylly Sanuelly da Paz Martins, Bianca Gomes de Gomes de Souza, Danielle Alice Vieira da Silva
article en

Abstract

Background/Objectives: This study aimed to evaluate the effects of oral administration of N-acetylcysteine (NAC) in pregnant women with preeclampsia (PE), using serum markers of redox imbalance and cytokine levels and perinatal outcomes. Methods: A double-blind, randomized, placebo-controlled pilot study was carried out from 2021 to 2023. The study was retrospectively registered with REBEC (Brazilian Clinical Trials Registry). After screening, women were randomized into 2 groups according to the type of supplementation: 600 mg of NAC (NAC group) or capsules containing 2% colloidal silicon dioxide and 98% microcrystalline cellulose (placebo group) until delivery. Blood samples were collected to quantify biomarkers of redox imbalance and cytokine levels. Questionnaires containing socioeconomic, clinical, obstetric, and anthropometric data were applied. Results: A total of 51 pregnant women with PE were included (26 in the placebo group and 25 in the NAC group). The use of NAC was associated with a higher gestational age at birth (GA) of the conceptus (placebo group: 37.39 weeks ± 1.96 SD vs. NAC group: 38.45 weeks ± 1.51 SD; p = 0.044). A moderate effect size was observed for this variable (Cohen’s d = 0.52). However, treatment allocation (NAC vs. control) was not independently associated with gestational age at birth after adjustment for covariates (F(1,28) = 0.144; p = 0.707; η2p = 0.005). The adjusted mean difference between groups was 0.92 weeks (95% CI: −0.16 to 2.00). No other significant effects on redox and inflammatory markers were identified using NAC. Conclusions: NAC supplementation did not impact the mode of delivery between the NAC and placebo groups. As a secondary exploratory finding, a possible trend toward prolonged gestational age was observed in the NAC group; however, this result should be interpreted with caution, given the exploratory nature of the analysis, the neutrality of the primary outcome, and the limited sample size.

PharmaceuticalsVol. 19(9)
Instituto Federal de Educação, Ciência e Tecnologia de Alagoas (BR), Universidade Federal de Alagoas (BR)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Good health and well-being
Openalex Percentile: Top 8%
Pregnancy and preeclampsia studies
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