Effects of N-acetylcysteine administration in treatment of women with gestational diabetes mellitus

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N71

Enrollment

Registered

2020-04-21

Start date

2020-02-04

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus. Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium

Interventions

Intervention 1: Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally. Intervention 2: Control group: Placebo tablet (Osve Pharmace

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women with gestational diabetes mellitus. Individuals aged 18 to 40 years.

Exclusion criteria

Exclusion criteria: Overt diabetes mellitus Taking any antioxidant agents 3 months before the intervention Needing insulin therapy Hypo and hyperthyroidism Unwillingness to cooperate

Design outcomes

Primary

Measure	Time frame
Insulin resistance. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Calculation using HOMA formula.	—

Secondary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Cesarean section rate. Timepoint: Delivery time. Method of measurement: checklist.;Preterm delivery. Timepoint: Delivery time. Method of measurement: checklist.;Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonography.;Pre-eclampsia rate. Timepoint: During intervention. Method of measurement: checklist.;Macrosomia rate. Timepoint: Delivery time. Method of measurement: checklist.;Low birth weight. Timepoint: Delivery time. Method of measurement: checklist.;Newborns’ hyperbilirubinemia. Timepoint: Delivery time. Method of measurement: checklist.;Newborns’ hospitalization. Timepoint: Delivery time. Method of measurement: checklist.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Cesarean section rate. Timepoint: Delivery time. Method of measurement: checklist.;Preterm delivery. Timepoint: Delivery time. Method of measurement: checklist.;Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonography.;Pre-eclampsia rate. Timepoint: During intervention. Method of measurement: checklist.;Macrosomia rate. Timepoint: Delivery time. Method of measurement: checklist.;Low birth weight. Timepoint: Delivery time. Method of measurement: checklist.;Newborns’ hyperbilirubinemia. Timepoint: Delivery time. Method of measurement: checklist.;Newborns’ hospitalization. Timepoint: Delivery time. Method of measurement: checklist.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Susan Assadpour

Kashan University of Medical Sciences

susanassadpour67@gmail.com+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026