ArticlePloS one2026
A randomized controlled trial of N-acetylcysteine in the treatment of early-onset preeclampsia: Study Protocol.
Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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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.
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Authors and funding
16 authors.
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Abstract
backgroundDespite significant advancements in obstetric care, the incidence of preeclampsia remains a substantial public health challenge, and effective strategies to prevent the disease progression remain limited, particularly in low-resource settings. N-acetylcysteine (NAC), an antioxidant and glutathione precursor, has demonstrated anti-inflammatory and vasodilatory effects, making it a promising candidate for repurposing. However, robust evidence from well-powered randomized controlled trials is lacking.
objectiveThis study will evaluate the impact of NAC on the time-to-disease progression in pregnant women with early-onset preeclampsia in Lagos, Nigeria.
methodsThis is the study protocol for a proof-of-concept, double-blind, randomized, controlled trial to be conducted between April 2026 to July 2028 at the maternity units of the two teaching hospitals in Lagos, Nigeria. At baseline, n = 153 sexually active women aged 18 years or older diagnosed with early-onset preeclampsia at 24-34 weeks' gestation will be randomised to receive either daily oral tablet containing 600 mg of NAC or a placebo tablet that is matched for appearance and the dosing regimen in addition to standard antenatal care from diagnosis (randomisation) until either 34 weeks' gestation or delivery, whichever comes first. The primary endpoint is the time-to-progression (in days) of early-onset preeclampsia to severe disease. The data analysis will be conducted on an intention-to-treat basis. Kaplan-Meier estimates with a Log-rank test will be used to calculate and compare the time-to-disease progression for the treatment groups, while Cox proportional hazard models with a backwards conditional method will be used to compare the primary endpoint between the treatment arms while adjusting for other covariates for precision using hazard ratios (HRs) and 95% confidence intervals (95%CIs). Subgroup analyses will also be performed to assess the differential effects of significant covariates on the impact of NAC on disease progression. Statistical significance will be reported as P < 0.05. DISCUSSION: This study will evaluate the efficacy of daily oral NAC compared to placebo in treating pregnant women with early-onset preeclampsia. If proven effective, NAC could offer a safe, affordable, and scalable intervention to reduce the burden of preeclampsia, particularly in resource-constrained settings.
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