Study of the effects of N-acetylcysteine administration on pregnancy outcomes and metabolic profiles in women with gestational diabetes mellitus

Objective: The aim of this study is to determine the effects of N-acetylcysteine administration on pregnancy outcomes and metabolic profiles in women with GDM.

Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive N-acetyl cystein (n=38) or placebo (n=38).

Among patients with GDM referred to Shahid Beheshti gynecology and obstetrics Clinic affiliated to Kashan University of Medical Sciences, 76 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Drugs and placebos are similar. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.

Inclusion criteria: Women with gestational diabetes aged 18 to 40 years. Exclusion criteria: Overt diabetes mellitus, taking any antioxidant agents 3 months before the intervention, needing insulin therapy, Hypo and hyperthyroidism, and Unwillingness to cooperate.

IIntervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally. Control group: Placebo tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.

Outcomes: Insulin resistance (primary outcome) and lipid profiles, biomarkers of inflammation and oxidative stress, and pregnancy outcomes (secondary outcomes) will be quantified at study baseline and end-of-trial.

The updating process was done before publishing the paper to correct the registration information.

Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 76 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Gynecology Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of drugs. Drugs and placebos are in the same packaging at the Osve pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, packet codes will be decoded. Participants, investigators or the assessors of the outcomes are unaware of the study groups.